A Study in Preterm Neonates With Respiratory Distress Syn... | NCT02772081

Label	Type	Description	Intervention Names
Curosurf LISA	Experimental	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed.	Combination Product: LISA combination product (Curosurf+catheter CHF6440)
Curosurf Endotracheal Tube	Active Comparator	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed.	Drug: Curosurf through conventional administration (endotracheal tube)

Name	Type	Description	Arm Group Labels	Other Names
LISA combination product (Curosurf+catheter CHF6440)	Combination Product	Curosurf administration through brief insertion of a thin catheter into the trachea	Curosurf LISA

Measure	Description	Time Frame
Safety: Study Treatment Administration: Number of Participants Who Received 1, 2, or 3 Doses of Treatment	Extent of exposure to study treatment is summarized by treatment group. Number of participants who received 1, 2, or 3 doses of treatment. All neonates received the first administration of Curosurf® 200 mg/kg. In case of lack of efficacy or clinical deterioration, a second dose of Curosurf® 100 mg/kg was administered using the same technique as the first dose. Neonates could receive a third Curosurf® 100 mg/kg dose if needed, administered using a standard technique. Results are presented as the number of neonates who received 1, 2, or 3 doses of Curosurf®, administered.	First 72 hours of life.
Safety: Study Treatment Administration: Number of Participants for Whom the First Attempt Failed to Insert the Catheter/Endotracheal Tube	Number of participants for whom the first attempt failed to insert the catheter/endotracheal tube and the percentage of neonates with first failed attempt, is presented by treatment group.	At first surfactant administration, up to Day 1.
Safety: Study Treatment Administration: Number of Maneuvers Discontinued Due to Neonate's Severe Destabilization	Number of manoeuvres (attempts) discontinued, due to neonate's severe destabilization is presented by treatment group.	At first surfactant administration, up to Day 1 or at second administration, up to 2 days.
Safety: Study Treatment Administration: Number of Attempts to First Successful Insertion	Number of attempts required to achieve first successful insertion is presented by treatment group.	At first surfactant administration, up to Day 1 or at second administration, up to 2 days.
Safety: Study Treatment Administration: Number of Device Misallocation for LISA Administration Group (Esophageal Insertion)

Measure	Description	Time Frame
Efficacy: Duration of Oxygen Alone Supplementation and Any Non-Invasive Ventilation (NIV)	The duration of oxygen alone supplementation and any non-invasive ventilation (NIV) during the study are presented by treatment group. PMA=Post-Menstrual Age PNA=Post-Natal Age	First 72 hours of life, Up to 28 days Post-Natal Age (PNA), Up to 36 weeks Post-Menstrual Age (PMA).

Name	Affiliation	Role
Rangasamy Ramanathan, M.D.	LAC+USC Medical Center & Good Samaritan Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Chiesi Clinical Trial Site 84029		Little Rock	Arkansas	72205	United States
Chiesi Clinical Trial Site 84001

Label	URL
Study Record on EU Clinical Trials Register including results	View source

ID	Title	Description
FG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 8, 2020	Aug 11, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Safety: Study Treatment Administration: Number of Participants Who Received 1, 2, or 3 Doses of Treatment

Extent of exposure to study treatment is summarized by treatment group. Number of participants who received 1, 2, or 3 doses of treatment.

All neonates received the first administration of Curosurf® 200 mg/kg. In case of lack of efficacy or clinical deterioration, a second dose of Curosurf® 100 mg/kg was administered using the same technique as the first dose. Neonates could receive a third Curosurf® 100 mg/kg dose if needed, administered using a standard technique. Results are presented as the number of neonates who received 1, 2, or 3 doses of Curosurf®, administered.

Safety population (SAF): All randomized neonates who received at least one dose of study treatment.

Posted

Count of Participants

Participants

First 72 hours of life.

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Units	Counts
Participants	OG00019 OG00112

Title

Denominators

Categories

Title	Measurements
Number of Curosurf® dose, n=1 dose	OG00013 OG0019
Number of Curosurf® doses, n=2 doses	OG000

Primary

Safety: Study Treatment Administration: Number of Participants for Whom the First Attempt Failed to Insert the Catheter/Endotracheal Tube

Number of participants for whom the first attempt failed to insert the catheter/endotracheal tube and the percentage of neonates with first failed attempt, is presented by treatment group.

Safety population (SAF): All randomized neonates who received at least one dose of study treatment.

Posted

Count of Participants

Participants

At first surfactant administration, up to Day 1.

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Primary

Safety: Study Treatment Administration: Number of Maneuvers Discontinued Due to Neonate's Severe Destabilization

Number of manoeuvres (attempts) discontinued, due to neonate's severe destabilization is presented by treatment group.

Safety population (SAF): All randomized neonates who received at least one dose of study treatment.

Posted

Mean

Full Range

Number of maneuvers (attempts)

At first surfactant administration, up to Day 1 or at second administration, up to 2 days.

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Primary

Safety: Study Treatment Administration: Number of Attempts to First Successful Insertion

Number of attempts required to achieve first successful insertion is presented by treatment group.

Safety population (SAF): All randomized neonates who received at least one dose of study treatment.

Posted

Mean

Full Range

Number of maneuvers (attempts)

At first surfactant administration, up to Day 1 or at second administration, up to 2 days.

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Primary

Safety: Study Treatment Administration: Number of Device Misallocation for LISA Administration Group (Esophageal Insertion)

Number of device misallocation for LISA administration group (esophageal insertion).

Data was not collected from participants in the "Curosurf Endotracheal Tube" -- the control arm of the study, because it is not applicable.

Safety population (SAF): All randomized neonates who received at least one dose of study treatment.

Posted

Mean

Full Range

Number of maneuvers (attempts)

At first surfactant administration, up to Day 1 or at second administration, up to 2 days.

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Primary

Safety: Study Treatment Administration: Duration of Surfactant Administration

Duration of surfactant administration is presented by treatment group.

Safety population (SAF): All randomized neonates who received at least one dose of study treatment.

Posted

Mean

Full Range

minutes

At first surfactant administration, up to Day 1 or at second administration, up to 2 days.

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Primary

Safety: Study Treatment Administration: Duration of the Whole Procedure

Duration of the whole procedure (starting from the insertion of laryngoscope up to the removal of the catheter/ETT), is presented by treatment group.

Safety population (SAF): All randomized neonates who received at least one dose of study treatment.

Posted

Mean

Full Range

minutes

At first surfactant administration, up to Day 1 or at second administration, up to 2 days.

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Secondary

Efficacy: Duration of Oxygen Alone Supplementation and Any Non-Invasive Ventilation (NIV)

The duration of oxygen alone supplementation and any non-invasive ventilation (NIV) during the study are presented by treatment group.

PMA=Post-Menstrual Age PNA=Post-Natal Age

Intention-to-treat population (ITT): All randomized neonates who received at least one dose of study treatment.

Posted

Mean

Full Range

days

First 72 hours of life, Up to 28 days Post-Natal Age (PNA), Up to 36 weeks Post-Menstrual Age (PMA).

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Secondary

Efficacy: Neonates Needing Additional 2 or 3 Doses of Surfactant

A summary of the percentage of neonates requiring at least one additional dose of surfactant, and respective statistical analysis, is presented by treatment group i.e. 2 or 3 doses of surfactant .

Intention-to-treat population (ITT): All randomized neonates who received at least one dose of study treatment.

Posted

Count of Participants

Participants

First 72 hours of life.

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Secondary

Efficacy: Neonates Needing Additional Surfactant Doses

A summary of the percentage of neonates requiring at least one additional dose of surfactant, and respective statistical analysis, is presented by treatment group.

Intention-to-treat population (ITT): All randomized neonates who received at least one dose of study treatment.

Posted

Count of Participants

Participants

First 72 hours of life.

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Secondary

Efficacy: Preductal Oxygen Saturation/Fraction of Inspired Oxygen (SpO2/FiO2) Ratio

The mean SpO2/FiO2 ratio values at timepoints up to and including 120 hours post-treatment, and respective statistical analyses, are summarized by treatment group.

Intention-to-treat population (ITT): All randomized neonates who received at least one dose of study treatment.

Posted

Mean

Standard Deviation

ratio

Pre-procedure, at time 0 (T0, end of surfactant instillation) and post treatment after T0 at 5, 15, 30 minutes, at 1, 6, 12, 24, 48, 72, and 120 hours, on Day 28 PNA, 36 weeks PMA.

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Secondary

Efficacy: Fraction of Inspired Oxygen (FiO2)

The FiO2 values at timepoints up to and including 120 hours post-treatment and the changes from pre-procedure to each of those timepoints are presented by treatment group.

The fraction of inspired oxygen (FiO2) is the concentration of oxygen in the gas mixture.

Intention-to-treat population (ITT): All randomized neonates who received at least one dose of study treatment.

Posted

Mean

Standard Deviation

fraction of inspired oxygen

Pre-procedure, at time 0 (T0, end of surfactant instillation) and post treatment after T0 at 5, 15, 30 minutes, at 1, 6, 12, 24, 48, 72, and 120 hours, on Day 28 PNA, 36 weeks PMA.

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Secondary

Efficacy: Preductal Oxygen Saturation (SpO2)

The mean SpO2 values at timepoints up to and including 120 hours post-treatment are summarized by treatment group.

Oxygen saturation (SpO2) is a measurement of how much oxygen the blood is carrying as a percentage of the maximum it could carry.

Intention-to-treat population (ITT): All randomized neonates who received at least one dose of study treatment.

Posted

Mean

Standard Deviation

percentage of oxygen saturation

Pre-procedure, at time 0 (T0, end of surfactant instillation) and post treatment after T0 at 5, 15, 30 minutes, at 1, 6, 12, 24, 48, 72, and 120 hours, on Day 28 PNA, 36 weeks PMA.

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Secondary

Efficacy: Percentage of Neonates Needing Any Intubation Procedure, Outside the Initial Surfactant Administration Period

The percentage of neonates needing any intubation procedure, outside the initial surfactant administration period (i.e., excluding endotracheal intubation[s] that were required for surfactant administration in the Conventional administration arm), in the first 72 hours of life, in the first 28 days post-natal age (PNA), and within 36 weeks Post-menstrual age (PMA), and respective statistical analyses, are presented.

Intention-to-treat population (ITT): All randomized neonates who received at least one dose of study treatment.

Posted

Number

percentage of participants

First 72 hours of life, up to 28 days post-natal age (PNA), Up to 36 weeks Post-menstrual age (PMA)

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Secondary

Efficacy: Median Duration of Invasive Mechanical Ventilation During the Study

The duration of invasive ventilation (MV) in the first 28 days PNA, and within 36 weeks PMA, are presented by treatment group.

Participants who actually received invasive ventilation are reported in the table below.

Intention-to-treat population (ITT): All randomized neonates who received at least one dose of study treatment.

Posted

Median

Full Range

days

Up to 28 days PNA, Up to 36 weeks PMA

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Secondary

Efficacy: Duration of Invasive Mechanical Ventilation During the Study

The duration of invasive ventilation (MV) in the first 72 hours of life and respective statistical analyses, are presented by treatment group.

Intention-to-treat population (ITT): All randomized neonates who received at least one dose of study treatment.

Posted

Median

Full Range

hours

First 72 hours of life

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Secondary

Efficacy: Percentage of Neonates Needing Invasive Mechanical Ventilation (MV) During the Study

The percentage of neonates needing invasive mechanical ventilation (MV) in the first 72 hours of life, in the first 28 days post-natal age (PNA), and within 36 weeks Post-Menstrual Age (PMA), and respective statistical analyses, are presented by treatment group.

Intention-to-treat population (ITT): All randomized neonates who received at least one dose of study treatment.

Posted

Count of Participants

Participants

First 72 hours of life, Up to 28 days Post-Natal Age (PNA), Up to 36 weeks PMA

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Secondary

Efficacy: Blood Gas Analysis Parameters -- pH

The blood gas analysis for blood pH at all timepoints and the changes from pre-procedure to each timepoint are presented.

Results for pH values are based on a scale of 0 to 14. A pH value of 7 is neutral, pH less than 7 is acidic, and pH greater than 7 is basic.

Intention-to-treat population (ITT): All randomized neonates who received at least one dose of study treatment.

Posted

Mean

Full Range

units on a pH scale

First 72 hours of life (1h, 6h, 24h, 48h, 72h)

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Secondary

Efficacy: Blood Gas Analysis Parameters -- Partial Pressure of Carbon Dioxide (pCO2)

The blood gas analysis partial pressure of carbon dioxide (pCO2) at all timepoints and the changes from pre-procedure to each timepoint are presented.

Intention-to-treat population (ITT): All randomized neonates who received at least one dose of study treatment.

Posted

Mean

Full Range

mmHg

First 72 hours of life (1h, 6h, 24h, 48h, 72h)

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Secondary

Efficacy: Blood Gas Analysis Parameters -- Partial Pressure of Oxygen (pO2)

The blood gas analysis partial pressure of oxygen (pO2) at all timepoints and the changes from pre-procedure to each timepoint are presented.

Intention-to-treat population (ITT): All randomized neonates who received at least one dose of study treatment.

Posted

Mean

Full Range

mmHg

First 72 hours of life (1h, 6h, 24h, 48h, 72h)

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Secondary

Efficacy: Blood Analysis Parameter -- Bicarbonate (HCO3^-)

The blood concentration of bicarbonate (HCO3^-) at all timepoints and the changes from pre-procedure to each timepoint are presented.

Intention-to-treat population (ITT): All randomized neonates who received at least one dose of study treatment.

Posted

Mean

Full Range

mmol/L

First 72 hours of life (1h, 6h, 24h, 48h, 72h)

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Secondary

Efficacy: Blood Analysis Parameter -- Base Excess

The blood base excess at all timepoints and the changes from pre-procedure to each timepoint are presented.

Base excess is defined as the amount of acid that must be added to each litre of fully oxygenated blood to return the pH to 7.40 at a temperature of 37°C and a pCO2 of 40 mmHg (5.3 kPa). The value is reported as a concentration in units of milliequivalent per liter (mEq/L), with positive numbers indicating an excess of base and negative a deficit.

Intention-to-treat population (ITT): All randomized neonates who received at least one dose of study treatment.

Posted

Mean

Full Range

mEq/L

First 72 hours of life (1h, 6h, 24h, 48h, 72h)

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Secondary

Efficacy: Blood Analysis Parameter -- Lactate

The blood concentration of lactate at all timepoints and the changes from pre-procedure to each timepoint are presented.

Intention-to-treat population (ITT): All randomized neonates who received at least one dose of study treatment.

Posted

Mean

Full Range

mmol/L

First 72 hours of life (1h, 6h, 24h, 48h, 72h)

ID	Title	Description
OG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
OG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia neonatal	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG00010 events10 affected19 at risk EG0014 events4 affected12 at risk
Thrombocytopenia neonatal	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0002 events2 affected19 at risk EG0011 events1 affected12 at risk
Bradycardia neonatal	Cardiac disorders	24.0	Systematic Assessment	EG0008 events7 affected19 at risk EG0011 events1 affected12 at risk
Neonatal tachycardia	Cardiac disorders	24.0	Systematic Assessment	EG0002 events2 affected19 at risk EG0012 events2 affected12 at risk
Supraventricular extrasystoles	Cardiac disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Hydrocele	Congenital, familial and genetic disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Patent ductus arteriosus	Cardiac disorders	24.0	Systematic Assessment	EG0006 events6 affected19 at risk EG0015 events5 affected12 at risk
Retinopathy of prematurity	Eye disorders	24.0	Systematic Assessment	EG0007 events7 affected19 at risk EG0015 events4 affected12 at risk
Abdominal distension	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0011 events1 affected12 at risk
Constipation	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0011 events1 affected12 at risk
Ileus	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Inguinal hernia	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Umbilical hernia	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected12 at risk
Vomiting	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Oedema neonatal	General disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Hyperbilirubinaemia neonatal	Hepatobiliary disorders	24.0	Systematic Assessment	EG00011 events11 affected19 at risk EG0015 events5 affected12 at risk
Neonatal cholestasis	Hepatobiliary disorders	24.0	Systematic Assessment	EG0002 events2 affected19 at risk EG0010 events0 affected12 at risk
Bacteraemia	Infections and infestations	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Cellulitis	Infections and infestations	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Conjunctivitis	Infections and infestations	24.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected12 at risk
Periumbilical abscess	Infections and infestations	24.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected12 at risk
Sepsis neonatal	Infections and infestations	24.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0013 events2 affected12 at risk
Staphylococcal bacteraemia	Infections and infestations	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0011 events1 affected12 at risk
Staphylococcal infection	Infections and infestations	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0012 events2 affected12 at risk
Urinary tract infection bacterial	Infections and infestations	24.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected12 at risk
Urinary tract infection neonatal	Infections and infestations	24.0	Systematic Assessment	EG0004 events3 affected19 at risk EG0011 events1 affected12 at risk
Blood creatinine increased	Investigations	24.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0012 events2 affected12 at risk
C-reactive protein increased	Investigations	24.0	Systematic Assessment	EG0002 events2 affected19 at risk EG0010 events0 affected12 at risk
Cardiac murmur	Investigations	24.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected12 at risk
Heart rate decreased	Investigations	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Alkalosis	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected12 at risk
Feeding intolerance	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Hyperglycaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Hyperkalaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected12 at risk
Hypermagnesaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0012 events2 affected12 at risk
Hypokalaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0002 events2 affected19 at risk EG0010 events0 affected12 at risk
Metabolic acidosis	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Neonatal hypocalcaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0011 events1 affected12 at risk
Neonatal hyponatraemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0005 events4 affected19 at risk EG0011 events1 affected12 at risk
Poor feeding infant	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0002 events2 affected19 at risk EG0010 events0 affected12 at risk
Acquired plagiocephaly	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Cerebral ventricle dilatation	Nervous system disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Intraventricular haemorrhage neonatal	Nervous system disorders	24.0	Systematic Assessment	EG0005 events4 affected19 at risk EG0011 events1 affected12 at risk
Periventricular leukomalacia	Nervous system disorders	24.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected12 at risk
Jaundice neonatal	Pregnancy, puerperium and perinatal conditions	24.0	Systematic Assessment	EG0002 events2 affected19 at risk EG0010 events0 affected12 at risk
Device occlusion	Product Issues	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Acute kidney injury	Renal and urinary disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Bronchopulmonary dysplasia	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0009 events9 affected19 at risk EG0015 events5 affected12 at risk
Chronic respiratory disease	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Infantile apnoea	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG00013 events13 affected19 at risk EG0015 events5 affected12 at risk
Laryngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected12 at risk
Neonatal hypoxia	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0008 events7 affected19 at risk EG0014 events4 affected12 at risk
Neonatal respiratory failure	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0011 events1 affected12 at risk
Neonatal tachypnoea	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Pulmonary haemorrhage neonatal	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0002 events2 affected19 at risk EG0010 events0 affected12 at risk
Pulmonary interstitial emphysema syndrome	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Respiration abnormal	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Skin disorder	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0003 events2 affected19 at risk EG0010 events0 affected12 at risk
Hypertension neonatal	Vascular disorders	24.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected12 at risk

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

ID	Title	Description
BG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea
BG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Curosurf LISA	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. LISA combination product (Curosurf+catheter CHF6440): Curosurf administration through brief insertion of a thin catheter into the trachea	1	19	1	19	19	19
EG001	Curosurf Endotracheal Tube	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Curosurf through conventional administration (endotracheal tube): Curosurf through conventional administration (endotracheal tube), followed by rapid extubation	1	12	2	12	12	12

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardio-respiratory arrest	Cardiac disorders	24.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected12 at risk
Cardiopulmonary failure	Cardiac disorders	24.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected12 at risk
Fungal sepsis	Infections and infestations	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Subdural haematoma	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected12 at risk
Intraventricular haemorrhage neonatal	Nervous system disorders	24.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected12 at risk
Pulmonary haemorrhage neonatal	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected12 at risk