SURFAXIN® Treatment for Prevention of Bronchopulmonary Dy... | NCT00215540

Label	Type	Description	Intervention Names
SURFAXIN High Dose	Experimental	SURFAXIN (lucinactant) at 175 mg/kg	Drug: Lucinactant 175 mg/kg
SURFAXIN Low Dose	Experimental	SURFAXIN (lucinactant) at 90 mg/kg	Drug: Lucinactant 90 mg/kg
Placebo	Placebo Comparator	Sham air using 3.0 mL/kg volume of air	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Lucinactant 175 mg/kg	Drug	Administered via slow intra-tracheal instillation at a dose of 175 mg/kg (5.8 mL/kg of a 30-mg/mL suspension). Initial treatment given no later than 1 hour after randomization. Additional treatments were administered every 48 hours up to a maximum of 5 doses (up to day of life (DOL) 18).

Measure	Description	Time Frame
Incidence of Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks	Number of participants who died or developed BPD, defined as oxygen requirement at 36 Weeks post-menstrual age	36 weeks post-menstrual age (PMA)
All-cause Mortality		36 weeks PMA

Measure	Description	Time Frame
BPD at 28 Days	BPD at 28 days of life, as determined by the need for supplemental oxygen	28 days of life
BPD at 36 Weeks	BPD at 36 weeks PMA as determined by the need for supplemental oxygen

Name	Affiliation	Role
Carlos Guardia, MD	Windtree Therapeutics	Study Director
Matthew M Laughon, MD, MPH	University of North Carolina, Chapel Hill	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Discovery Laboratories, Inc.		Warrington	Pennsylvania	18976-3646	United States

PubMed Identifier	Type	Citation	Retractions
19117865	Result	Laughon M, Bose C, Moya F, Aschner J, Donn SM, Morabito C, Cummings JJ, Segal R, Guardia C, Liu G; Surfaxin Study Group. A pilot randomized, controlled trial of later treatment with a peptide-containing, synthetic surfactant for the prevention of bronchopulmonary dysplasia. Pediatrics. 2009 Jan;123(1):89-96. doi: 10.1542/peds.2007-2680.

ID	Title	Description
FG000	SURFAXIN High Dose	SURFAXIN (lucinactant) at 175 mg/kg
FG001	SURFAXIN Low Dose	SURFAXIN (lucinactant) at 90 mg/kg

ID	Title	Description
BG000	SURFAXIN High Dose	SURFAXIN (lucinactant) at 175 mg/kg
BG001	SURFAXIN Low Dose	SURFAXIN (lucinactant) at 90 mg/kg
BG002	Placebo	Sham air using 3.0 mL/kg volume of air
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00045 BG00147 BG00244 BG003136

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

Incidence of Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks

Number of participants who died or developed BPD, defined as oxygen requirement at 36 Weeks post-menstrual age

A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)

Posted

Number

participants

36 weeks post-menstrual age (PMA)

ID	Title	Description
OG000	SURFAXIN High Dose	SURFAXIN (lucinactant) at 175 mg/kg
OG001	SURFAXIN Low Dose	SURFAXIN (lucinactant) at 90 mg/kg
OG002	Placebo	Sham air using 3.0 mL/kg volume of air

Units	Counts
Participants	OG00045 OG00147 OG00244

Title

Denominators

Categories

Title	Measurements
	OG00026 OG00137 OG00229

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Null hypothesis: No difference between treatment groups	Cochran-Mantel-Haenszel	Adjusting for pooled study center	0.476							95						No	Superiority or Other
OG001 OG002	Null hypothesis: No difference between treatment groups

Primary

All-cause Mortality

A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)

Posted

Number

participants

36 weeks PMA

ID	Title	Description
OG000	SURFAXIN High Dose	SURFAXIN (lucinactant) at 175 mg/kg
OG001	SURFAXIN Low Dose	SURFAXIN (lucinactant) at 90 mg/kg
OG002	Placebo	Sham air using 3.0 mL/kg volume of air

Units	Counts
Participants	OG000

Secondary

BPD at 28 Days

BPD at 28 days of life, as determined by the need for supplemental oxygen

A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)

Posted

Number

participants

28 days of life

ID	Title	Description
OG000	SURFAXIN High Dose	SURFAXIN (lucinactant) at 175 mg/kg
OG001	SURFAXIN Low Dose	SURFAXIN (lucinactant) at 90 mg/kg
OG002	Placebo	Sham air using 3.0 mL/kg volume of air

Units	Counts
Participants	OG000

Secondary

BPD at 36 Weeks

BPD at 36 weeks PMA as determined by the need for supplemental oxygen

A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)

Posted

Number

participants

36 weeks PMA

ID	Title	Description
OG000	SURFAXIN High Dose	SURFAXIN (lucinactant) at 175 mg/kg
OG001	SURFAXIN Low Dose	SURFAXIN (lucinactant) at 90 mg/kg
OG002	Placebo	Sham air using 3.0 mL/kg volume of air

Units	Counts
Participants	OG000

Secondary

Days Receiving Mechanical Ventilation (MV)

Number of days receiving mechanical ventilation

A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)

Posted

Mean

Standard Deviation

days

36 weeks PMA

ID	Title	Description
OG000	SURFAXIN High Dose	SURFAXIN (lucinactant) at 175 mg/kg
OG001	SURFAXIN Low Dose	SURFAXIN (lucinactant) at 90 mg/kg
OG002	Placebo	Sham air using 3.0 mL/kg volume of air

Units	Counts
Participants	OG000

Secondary

Duration of Supplemental Oxygen

Number of days receiving supplemental oxygen through 36 weeks PMA

A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)

Posted

Mean

Standard Deviation

days

36 weeks PMA

ID	Title	Description
OG000	SURFAXIN High Dose	SURFAXIN (lucinactant) at 175 mg/kg
OG001	SURFAXIN Low Dose	SURFAXIN (lucinactant) at 90 mg/kg
OG002	Placebo	Sham air using 3.0 mL/kg volume of air

Units	Counts
Participants	OG000

Secondary

Area Under the Curve for Fraction of Inspired Oxygen (FiO₂)

AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward

A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)

Posted

Mean

Standard Deviation

Percent O₂*hour

15 minutes prior to dose 1, 2 hours post dose 1, 6 hours post dose 1, 24 hours post dose 1, and daily from Study Day 2 to Study Day 25 and Day of Life 28

ID	Title	Description
OG000	SURFAXIN High Dose	SURFAXIN (lucinactant) at 175 mg/kg
OG001	SURFAXIN Low Dose	SURFAXIN (lucinactant) at 90 mg/kg
OG002	Placebo	Sham air using 3.0 mL/kg volume of air

Units	Counts
Participants

Secondary

Area Under the Curve for Mean Arterial Pressure (MAP)

AUC for MAP (in mm Hg) calculated using the trapezoidal rule. Missing data imputed using last observation carried forward

A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)

Posted

Mean

Standard Deviation

arterial pressure (mm Hg)*hour

15 minutes prior to dose 1, 2 hours post dose 1, 6 hours post dose 1, 24 hours post dose 1, and daily from Study Day 2 to Study Day 25, and day of life 28

ID	Title	Description
OG000	SURFAXIN High Dose	SURFAXIN (lucinactant) at 175 mg/kg
OG001	SURFAXIN Low Dose	SURFAXIN (lucinactant) at 90 mg/kg
OG002	Placebo	Sham air using 3.0 mL/kg volume of air

Units	Counts
Participants

Secondary

Incidence of Death or BPD at 28 Days

Death or BPD, defined as oxygen requirement at 28 days of life

A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)

Posted

Number

participants

28 days of life

ID	Title	Description
OG000	SURFAXIN High Dose	SURFAXIN (lucinactant) at 175 mg/kg
OG001	SURFAXIN Low Dose	SURFAXIN (lucinactant) at 90 mg/kg
OG002	Placebo	Sham air using 3.0 mL/kg volume of air

Units	Counts
Participants	OG000

Secondary

Days in Hospital

The number of days spent in the hospital through 36 weeks PMA

A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)

Posted

Mean

Standard Deviation

days

36 weeks PMA

ID	Title	Description
OG000	SURFAXIN High Dose	SURFAXIN (lucinactant) at 175 mg/kg
OG001	SURFAXIN Low Dose	SURFAXIN (lucinactant) at 90 mg/kg
OG002	Placebo	Sham air using 3.0 mL/kg volume of air

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected47 at risk EG0020 events0 affected44 at risk
Bradycardia NOS	Cardiac disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected45 at risk EG0012 events2 affected47 at risk EG0021 events1 affected44 at risk
Cardiac arrest	Cardiac disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected47 at risk EG0022 events1 affected44 at risk
Cardiac arrest neonatal	Cardiac disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected47 at risk EG0020 events0 affected44 at risk
Cardio-respiratory arrest neonatal	Cardiac disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected47 at risk EG0020 events0 affected44 at risk
Pericardial effusion	Cardiac disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected47 at risk EG0021 events1 affected44 at risk
Patent ductus arteriosus	Congenital, familial and genetic disorders	MedDRA (6.1)	Systematic Assessment	EG0003 events3 affected45 at risk EG0013 events3 affected47 at risk EG0021 events1 affected44 at risk
Retrolental fibro-dysplasia	Eye disorders	MedDRA (6.1)	Systematic Assessment	EG0008 events8 affected45 at risk EG0019 events9 affected47 at risk EG0028 events8 affected44 at risk
Ileal perforation	Gastrointestinal disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected45 at risk EG0011 events1 affected47 at risk EG0021 events1 affected44 at risk
Ileus	Gastrointestinal disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected47 at risk EG0022 events1 affected44 at risk
Inguinal hernia NOS	Gastrointestinal disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected47 at risk EG0020 events0 affected44 at risk
Intestinal obstruction NOS	Gastrointestinal disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected47 at risk EG0021 events1 affected44 at risk
Intestinal perforation NOS	Gastrointestinal disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected47 at risk EG0020 events0 affected44 at risk
Meconium ileus	Gastrointestinal disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected45 at risk EG0011 events1 affected47 at risk EG0020 events0 affected44 at risk
Necrotising enterocolitis	Gastrointestinal disorders	MedDRA (6.1)	Systematic Assessment	EG0004 events4 affected45 at risk EG0015 events5 affected47 at risk EG0021 events1 affected44 at risk
Peritonitis	Gastrointestinal disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected47 at risk EG0021 events1 affected44 at risk
Multi-organ failure	General disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected47 at risk EG0020 events0 affected44 at risk
Bacteraemia	Infections and infestations	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected47 at risk EG0021 events1 affected44 at risk
Bronchopneumonia NOS	Infections and infestations	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected47 at risk EG0020 events0 affected44 at risk
Neonatal meningitis	Infections and infestations	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected47 at risk EG0020 events0 affected44 at risk
Pneumonia NOS	Infections and infestations	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected45 at risk EG0011 events1 affected47 at risk EG0022 events1 affected44 at risk
Sepsis NOS	Infections and infestations	MedDRA (6.1)	Systematic Assessment	EG0004 events4 affected45 at risk EG0010 events0 affected47 at risk EG0021 events1 affected44 at risk
Sepsis neonatal	Infections and infestations	MedDRA (6.1)	Systematic Assessment	EG0003 events3 affected45 at risk EG0016 events6 affected47 at risk EG0026 events6 affected44 at risk
Septic shock	Infections and infestations	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected47 at risk EG0021 events1 affected44 at risk
Septicaemia serratia	Infections and infestations	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected47 at risk EG0021 events1 affected44 at risk
Septicaemia staphylococcal	Infections and infestations	MedDRA (6.1)	Systematic Assessment	EG0004 events4 affected45 at risk EG0015 events5 affected47 at risk EG0024 events4 affected44 at risk
Abrasion NOS	Injury, poisoning and procedural complications	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected47 at risk EG0021 events1 affected44 at risk
Oxygen saturation decreased	Investigations	MedDRA (6.1)	Systematic Assessment	EG0002 events2 affected45 at risk EG0018 events4 affected47 at risk EG0022 events2 affected44 at risk
Diabetes mellitus NOS	Metabolism and nutrition disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected47 at risk EG0021 events1 affected44 at risk
Metabolic acidosis NOS	Metabolism and nutrition disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected47 at risk EG0021 events1 affected44 at risk
Muscle rigidity	Musculoskeletal and connective tissue disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected47 at risk EG0021 events1 affected44 at risk
Convulsions NOS	Nervous system disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected47 at risk EG0021 events1 affected44 at risk
Hydrocephalus NOS	Nervous system disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected45 at risk EG0011 events1 affected47 at risk EG0020 events0 affected44 at risk
Neurological disorder NOS	Nervous system disorders	MedDRA (6.1)	Systematic Assessment	EG0003 events3 affected45 at risk EG0013 events3 affected47 at risk EG0021 events1 affected44 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected47 at risk EG0021 events1 affected44 at risk
Renal failure neonatal	Renal and urinary disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0015 events5 affected47 at risk EG0021 events1 affected44 at risk
Urinary tract infection NOS neonatal	Renal and urinary disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected47 at risk EG0021 events1 affected44 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0012 events1 affected47 at risk EG0020 events0 affected44 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0010 events0 affected47 at risk EG0021 events1 affected44 at risk
Atelectasis neonatal	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected47 at risk EG0020 events0 affected44 at risk
Bronchopulmonary dysplasia	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0006 events6 affected45 at risk EG0018 events7 affected47 at risk EG0029 events9 affected44 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0014 events2 affected47 at risk EG0020 events0 affected44 at risk
Neonatal apnoeic attack	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected45 at risk EG0013 events3 affected47 at risk EG0022 events2 affected44 at risk
Neonatal hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0005 events2 affected45 at risk EG0011 events1 affected47 at risk EG0020 events0 affected44 at risk
Neonatal respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected45 at risk EG0011 events1 affected47 at risk EG0020 events0 affected44 at risk
Neonatal respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0002 events2 affected45 at risk EG0011 events1 affected47 at risk EG0020 events0 affected44 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected47 at risk EG0020 events0 affected44 at risk
Pneumothorax NOS	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0007 events5 affected45 at risk EG0015 events5 affected47 at risk EG0023 events3 affected44 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0002 events1 affected45 at risk EG0010 events0 affected47 at risk EG0021 events1 affected44 at risk
Pulmonary interstitial emphysema syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected47 at risk EG0022 events2 affected44 at risk
Patent ductus arteriosus repair	Surgical and medical procedures	MedDRA (6.1)	Systematic Assessment	EG0007 events7 affected45 at risk EG0018 events8 affected47 at risk EG0028 events8 affected44 at risk
Circulatory failure neonatal	Vascular disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected47 at risk EG0020 events0 affected44 at risk
Intracranial haemorrhage NOS	Vascular disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0011 events1 affected47 at risk EG0020 events0 affected44 at risk
Intraventricular haemorrhage neonatal	Vascular disorders	MedDRA (6.1)	Systematic Assessment	EG0004 events4 affected45 at risk EG0019 events9 affected47 at risk EG0028 events7 affected44 at risk
Neonatal hypotension	Vascular disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected45 at risk EG0011 events1 affected47 at risk EG0021 events1 affected44 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia NOS	Blood and lymphatic system disorders	MedDRA (6.1)	Systematic Assessment	EG00027 events10 affected45 at risk EG0018 events6 affected47 at risk EG00220 events8 affected44 at risk
Anaemia neonatal	Blood and lymphatic system disorders	MedDRA (6.1)	Systematic Assessment	EG00041 events24 affected45 at risk EG00137 events25 affected47 at risk EG00238 events25 affected44 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected47 at risk EG0025 events5 affected44 at risk
Thrombocytopenia neonatal	Blood and lymphatic system disorders	MedDRA (6.1)	Systematic Assessment	EG0006 events6 affected45 at risk EG0018 events7 affected47 at risk EG00210 events10 affected44 at risk
Bradycardia NOS	Cardiac disorders	MedDRA (6.1)	Systematic Assessment	EG00029 events16 affected45 at risk EG00151 events20 affected47 at risk EG00211 events8 affected44 at risk
Neonatal tachycardia	Cardiac disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0012 events2 affected47 at risk EG0023 events3 affected44 at risk
Patent ductus arteriosus	Congenital, familial and genetic disorders	MedDRA (6.1)	Systematic Assessment	EG00015 events14 affected45 at risk EG00113 events11 affected47 at risk EG00216 events16 affected44 at risk
Hypothyroidism	Endocrine disorders	MedDRA (6.1)	Systematic Assessment	EG0003 events3 affected45 at risk EG0012 events2 affected47 at risk EG0024 events4 affected44 at risk
Retrolental fibro-dysplasia	Eye disorders	MedDRA (6.1)	Systematic Assessment	EG00030 events27 affected45 at risk EG00135 events29 affected47 at risk EG00235 events29 affected44 at risk
Gastro-oesophageal reflux disease	Gastrointestinal disorders	MedDRA (6.1)	Systematic Assessment	EG0006 events6 affected45 at risk EG00112 events12 affected47 at risk EG0029 events9 affected44 at risk
Inguinal hernia NOS	Gastrointestinal disorders	MedDRA (6.1)	Systematic Assessment	EG0007 events5 affected45 at risk EG0017 events7 affected47 at risk EG0024 events4 affected44 at risk
Necrotising enterocolitis	Gastrointestinal disorders	MedDRA (6.1)	Systematic Assessment	EG0008 events8 affected45 at risk EG00110 events10 affected47 at risk EG0025 events5 affected44 at risk
Oedema NOS	General disorders	MedDRA (6.1)	Systematic Assessment	EG0002 events2 affected45 at risk EG0011 events1 affected47 at risk EG0027 events7 affected44 at risk
Cholestasis	Hepatobiliary disorders	MedDRA (6.1)	Systematic Assessment	EG0003 events3 affected45 at risk EG0012 events2 affected47 at risk EG0026 events6 affected44 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (6.1)	Systematic Assessment	EG0004 events4 affected45 at risk EG0013 events3 affected47 at risk EG0028 events8 affected44 at risk
Hypoproteinaemia	Hepatobiliary disorders	MedDRA (6.1)	Systematic Assessment	EG0002 events2 affected45 at risk EG0012 events2 affected47 at risk EG0024 events4 affected44 at risk
Bacteraemia	Infections and infestations	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0012 events2 affected47 at risk EG0024 events3 affected44 at risk
Pneumonia NOS	Infections and infestations	MedDRA (6.1)	Systematic Assessment	EG0007 events7 affected45 at risk EG0016 events6 affected47 at risk EG0026 events4 affected44 at risk
Sepsis NOS	Infections and infestations	MedDRA (6.1)	Systematic Assessment	EG0005 events4 affected45 at risk EG0013 events3 affected47 at risk EG0025 events3 affected44 at risk
Sepsis Neonatal	Infections and infestations	MedDRA (6.1)	Systematic Assessment	EG0008 events7 affected45 at risk EG00119 events17 affected47 at risk EG00215 events12 affected44 at risk
Septicaemia staphylococcal	Infections and infestations	MedDRA (6.1)	Systematic Assessment	EG00014 events13 affected45 at risk EG00114 events13 affected47 at risk EG00215 events14 affected44 at risk
Tracheitis NOS	Infections and infestations	MedDRA (6.1)	Systematic Assessment	EG0002 events2 affected45 at risk EG0018 events5 affected47 at risk EG0025 events3 affected44 at risk
Urinary tract infection fungal	Infections and infestations	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0013 events3 affected47 at risk EG0020 events0 affected44 at risk
Abrasion NOS	Injury, poisoning and procedural complications	MedDRA (6.1)	Systematic Assessment	EG0002 events2 affected45 at risk EG0013 events3 affected47 at risk EG0026 events6 affected44 at risk
Blood in stool	Investigations	MedDRA (6.1)	Systematic Assessment	EG0003 events3 affected45 at risk EG0011 events1 affected47 at risk EG0023 events3 affected44 at risk
Oxygen saturation decreased	Investigations	MedDRA (6.1)	Systematic Assessment	EG00042 events17 affected45 at risk EG00140 events18 affected47 at risk EG00222 events16 affected44 at risk
Acidosis NOS	Metabolism and nutrition disorders	MedDRA (6.1)	Systematic Assessment	EG0003 events3 affected45 at risk EG0010 events0 affected47 at risk EG0023 events3 affected44 at risk
Hyperglycaemia NOS	Metabolism and nutrition disorders	MedDRA (6.1)	Systematic Assessment	EG00011 events10 affected45 at risk EG00111 events9 affected47 at risk EG0027 events7 affected44 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0013 events3 affected47 at risk EG0021 events1 affected44 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA (6.1)	Systematic Assessment	EG0005 events5 affected45 at risk EG0010 events0 affected47 at risk EG0023 events3 affected44 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected45 at risk EG0010 events0 affected47 at risk EG0024 events4 affected44 at risk
Hypoglycaemia neonatal	Metabolism and nutrition disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected45 at risk EG0013 events3 affected47 at risk EG0022 events2 affected44 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (6.1)	Systematic Assessment	EG0005 events3 affected45 at risk EG0013 events3 affected47 at risk EG0025 events5 affected44 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (6.1)	Systematic Assessment	EG00014 events11 affected45 at risk EG00119 events15 affected47 at risk EG00215 events13 affected44 at risk
Metabolic acidosis NOS	Metabolism and nutrition disorders	MedDRA (6.1)	Systematic Assessment	EG0004 events4 affected45 at risk EG00111 events9 affected47 at risk EG0029 events9 affected44 at risk
Osteopenia	Metabolism and nutrition disorders	MedDRA (6.1)	Systematic Assessment	EG0003 events3 affected45 at risk EG0011 events1 affected47 at risk EG0023 events3 affected44 at risk
Convulsions NOS	Nervous system disorders	MedDRA (6.1)	Systematic Assessment	EG0004 events4 affected45 at risk EG0016 events6 affected47 at risk EG00210 events8 affected44 at risk
Neurological disorder NOS	Nervous system disorders	MedDRA (6.1)	Systematic Assessment	EG0005 events5 affected45 at risk EG0013 events3 affected47 at risk EG0022 events2 affected44 at risk
Renal failure neonatal	Renal and urinary disorders	MedDRA (6.1)	Systematic Assessment	EG0002 events2 affected45 at risk EG0018 events8 affected47 at risk EG0026 events6 affected44 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected45 at risk EG0017 events5 affected47 at risk EG0023 events3 affected44 at risk
Atelectasis neonatal	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0003 events3 affected45 at risk EG0014 events4 affected47 at risk EG0023 events3 affected44 at risk
Bronchopulmonary dysplasia	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG00039 events39 affected45 at risk EG00136 events34 affected47 at risk EG00238 events37 affected44 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0006 events4 affected45 at risk EG0019 events6 affected47 at risk EG0023 events3 affected44 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG00013 events6 affected45 at risk EG0015 events4 affected47 at risk EG0022 events2 affected44 at risk
Neonatal apnoeic attack	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG00016 events15 affected45 at risk EG00120 events18 affected47 at risk EG00216 events14 affected44 at risk
Neonatal hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG00041 events18 affected45 at risk EG00175 events25 affected47 at risk EG00210 events7 affected44 at risk
Neonatal respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0004 events3 affected45 at risk EG0015 events5 affected47 at risk EG0022 events2 affected44 at risk
Neonatal respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0008 events7 affected45 at risk EG0011 events1 affected47 at risk EG0022 events2 affected44 at risk
Pneumothorax NOS	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0007 events5 affected45 at risk EG0017 events7 affected47 at risk EG0023 events3 affected44 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0003 events2 affected45 at risk EG0011 events1 affected47 at risk EG0026 events6 affected44 at risk
Pulmonary interstitial emphysema syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0003 events3 affected45 at risk EG0016 events6 affected47 at risk EG0027 events7 affected44 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0003 events1 affected45 at risk EG0012 events1 affected47 at risk EG0023 events3 affected44 at risk
Respiratory failure (exc neonatal)	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0004 events4 affected45 at risk EG0014 events4 affected47 at risk EG0024 events4 affected44 at risk
Patent ductus arteriosus repair	Surgical and medical procedures	MedDRA (6.1)	Systematic Assessment	EG0008 events8 affected45 at risk EG0018 events8 affected47 at risk EG0028 events8 affected44 at risk
Hypertension neonatal	Vascular disorders	MedDRA (6.1)	Systematic Assessment	EG0003 events3 affected45 at risk EG0011 events1 affected47 at risk EG0020 events0 affected44 at risk
Intraventricular haemorrhage neonatal	Vascular disorders	MedDRA (6.1)	Systematic Assessment	EG00018 events17 affected45 at risk EG00126 events25 affected47 at risk EG00219 events17 affected44 at risk
Neonatal hypotension	Vascular disorders	MedDRA (6.1)	Systematic Assessment	EG0005 events5 affected45 at risk EG0018 events8 affected47 at risk EG0025 events5 affected44 at risk

ID	Term
D012127	Respiratory Distress Syndrome, Newborn
D047928	Premature Birth
D001997	Bronchopulmonary Dysplasia

ID	Term
D012128	Respiratory Distress Syndrome
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders
D007235	Infant, Premature, Diseases
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D055397	Ventilator-Induced Lung Injury
D055370	Lung Injury

ID	Term
D020313	Specialty Uses of Chemicals
D020164	Chemical Actions and Uses

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SURFAXIN High Dose	SURFAXIN (lucinactant) at 175 mg/kg	33	45	45	45
EG001	SURFAXIN Low Dose	SURFAXIN (lucinactant) at 90 mg/kg	36	47	47	47
EG002	Placebo	Sham air using 3.0 mL/kg volume of air	35	44	44	44