Newborn Ventilation in the Delivery Room: Could it be Imp... | NCT00443118

NCT00443118

Status Module

Sponsor/Collaborators Module

Name	Class
University of Alabama at Birmingham	OTHER

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neopuff TM with PEEP	Active Comparator	Newborns ventilated for neonatal resuscitation using Neopuff TM with PEEP	Device: T-piece resuscitator Neopuff TM
Self Inflating Bag with PEEP	Active Comparator	Newborns ventilated for neonatal resuscitation using Self Inflating Bag with PEEP valve attached	Device: Self Inflating Bag with PEEP
Self Inflating Bag without PEEP	Active Comparator	Newborns ventilated for neonatal resuscitationusing Self Inflating Bag without PEEP valve attached	Device: Self Inflating Bag without PEEP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
T-piece resuscitator Neopuff TM	Device	Positive pressure ventilation will be performed with Neopuff® with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.

Outcomes Module

Measure	Description	Time Frame
Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life.		2 minutes of life

Secondary Outcomes

Measure	Description	Time Frame
Time the Newborn Takes to Reach a HR > 100 Bpm		2 minutes of life
• SpO2 Value at 2 Minutes of Life.		2 minutes of life
• Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask.

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Edgardo Szyld, MD	Fundasamin	Principal Investigator
Adriana Aguilar, MD	Hospital Paroissien	Study Director
Waldemar Carlo, MD	University of Alabama at Birmingham	Study Chair
Nestor Vain, MD	Sanatorio de la Trinidad	Study Director
Luis Prudent, MD	Sanatorio Otamendi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Carol Jo Vecchie Women and Children's Center at St. John's Hospital		Springfield	Illinois	19676	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24690329	Derived	Szyld E, Aguilar A, Musante GA, Vain N, Prudent L, Fabres J, Carlo WA; Delivery Room Ventilation Devices Trial Group. Comparison of devices for newborn ventilation in the delivery room. J Pediatr. 2014 Aug;165(2):234-239.e3. doi: 10.1016/j.jpeds.2014.02.035. Epub 2014 Mar 29.

Label	URL
this paper was published on The Journal of Pediatrics	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

ID	Title	Description
FG000	T-Piece	Subjects assigned to be resuscitated with T-Piece
FG001	SIB - With PEEP Valve	Subjects allocated to SIB with a PEEP valve attached

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Neopuff TM with PEEP

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	T-Piece	Subjects assigned to be resuscitated with T-Piece
BG001	Self Inflating Bag With PEEP	Subjects allocated to Self Inflating Bag with PEEP
BG002	Self Inflating Bag Without PEEP	Subjects allocated to Self Inflating Bag without PEEP
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG000511 BG001290 BG002226 BG0031027

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Maternal age. As the subjects are all newborns, the baseline important data includes Maternal data

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00028± 7 BG00128± 7 BG00227± 7 BG003

Age, Continuous

Gestational age of enrolled infants

Mean

Standard Deviation

weeks

Title

Denominators

Categories

Title	Measurements
	BG00036± 4.1 BG00135± 5 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000208 BG001117 BG002

previous deliveries

Number

number of participants

Title

Denominators

Categories

primiparous

Title	Measurements
	BG000220 BG001137 BG002

ANTENATAL STEROIDS

Number

participants

Title

Denominators

Categories

YES

Title	Measurements
	BG000142 BG00184 BG002

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

Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life.

The analysis was performed by intention to treat

Posted

Number

percentage of participants

2 minutes of life

ID	Title	Description
OG000	T-Piece	Subjects assigned to be resuscitated with T-Piece
OG001	SIB - Self Inflating Bag With PEEP Valve	Subjects allocated to SIB with PEEP valve attached
OG002	SIB-Without PEEP Valve	Subjects allocated to SIB-Without PEEP valve attached

Units	Counts
Participants	OG000511 OG001290 OG002226

Title

Denominators

Categories

Title	Measurements
	OG00093.7 OG00188 OG00293

Secondary

Time the Newborn Takes to Reach a HR > 100 Bpm

Posted

Mean

Inter-Quartile Range

minutes

2 minutes of life

ID	Title	Description
OG000	T-Piece	Subjects assigned to be resuscitated with T-Piece
OG001	SIB - Self Inflating Bag With PEEP Valve	Subjects allocated to Self Inflating Bag with PEEP valve
OG002	SIB-Without PEEP Valve	Subjects allocated to Self Inflating Bag withouth a PEEP valve

Units	Counts
Participants	OG000

Secondary

• SpO2 Value at 2 Minutes of Life.

the pulse-oximeter was reliable at 2 minutes in 69% of the cases in both groups.

Posted

Mean

Standard Deviation

percentage of oxygen saturation

2 minutes of life

ID	Title	Description
OG000	T-Piece	Subjects assigned to be resuscitated with T-Piece
OG001	SIB - Self Inflating Bag With PEEP Valve	Subjects allocated to be ventilated using a Self Inlfating Bag with PEEP valve
OG002	SIB-Without PEEP Valve	Sujects allocated to be ventilated with Self Inflating Bag Without PEEP valve

Units	Counts
Participants	OG000

Secondary

• Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask.

Posted

Number

percentage of participants

after 2 minutes of life

ID	Title	Description
OG000	T-Piece	Subjects assigned to be resuscitated with T-Piece
OG001	SIB - Self Inflating Bag With PEEP Valve	Subjects allocated to Self Inflating Bag with a PEEP valve attached
OG002	SIB-Without PEEP Valve	Subjects allocated to Self Inflating Bag without PEEP valve

Units	Counts
Participants	OG000

Secondary

• Need for Chest Compression and/or Medications

Posted

Number

participants

after 2 minutes of life

ID	Title	Description
OG000	T-Piece	Subjects assigned to be resuscitated with T-Piece
OG001	SIB - Self Inflating Bag With PEEP Valve	Subjects allocated to SIB with PEEP valve
OG002	SIB-Without PEEP Valve	Subjects Allocated to SIB without PEEP valve

Units	Counts
Participants	OG000

Secondary

Apgar Scores at 1 and 5 Minutes

categorized Apgar score 1 min <=3 and categorized Apgar score 5 min <=5 The Apgar score is applied routinely by nurses and neonatologists to describe how vigorous the baby is at birth, it ranges from 0 to 10, with higher scores representing better outcomes.

Posted

Number

participants

1-5 minutes of life

ID	Title	Description
OG000	T-Piece	Subjects assigned to be resuscitated with T-Piece
OG001	SIB - Self Inflating Bag With PEEP Valve	Subjects allocated to Self Inflating Bag with PEEP valve
OG002	SIB-Without PEEP Valve	Subjects allocated to Self Inflating Bag Without PEEP valve

Units	Counts
Participants	OG000

Secondary

• Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat)

Posted

Number

participants

first week of life

ID	Title	Description
OG000	T-Piece	Subjects assigned to be resuscitated with T-Piece
OG001	SIB - Self Inflating Bag With PEEP Valve	Subjects allocated to Self Inflating Bag with PEEP valve
OG002	SIB-Without PEEP Valve	Self Inflating Bag without PEEP valve

Units	Counts
Participants	OG000

Secondary

• Incidence of Air Leaks

included pneumothorax and Pneumomediastinum

Posted

Number

participants

after birth and during hospitalization up to four weeks

ID	Title	Description
OG000	T-Piece	Subjects assigned to be resuscitated with T-Piece
OG001	SIB - Self Inflating Bag With PEEP Valve	Subjects allocated to Self Inflating Bag with PEEP valve
OG002	SIB-Without PEEP Valve	Subjects allocated to SIB-Without PEEP valve

Units	Counts
Participants	OG000

Secondary

• Use of Oxygen Treatment Beyond the Delivery Room

Posted

Number

participants/

during hospitalization

ID	Title	Description
OG000	T-Piece	Subjects assigned to be resuscitated with T-Piece
OG001	SIB - Self Inflating Bag With PEEP Valve	Subjects allocated to Self Inflating Bag with PEEP valve
OG002	SIB-Without PEEP Valve	subjects allocated to SIB-Without PEEP valve

Units	Counts
Participants	OG000

Secondary

Days on Oxygen

Posted

Mean

Standard Deviation

days

after birth and during hospitalization up to four weeks

ID	Title	Description
OG000	T-Piece	Subjects assigned to be resuscitated with T-Piece
OG001	SIB - Self Inflating Bag With PEEP Valve	Subjects allocated to Self Inflating Bag with PEEP valve
OG002	SIB-Without PEEP Valve	subjects allocated to SIB-Without PEEP valve

Units	Counts
Participants	OG000

Secondary

• Need for Mechanical Ventilation or CPAP

Posted

Number

participants

during hospitalization

ID	Title	Description
OG000	T-Piece	Subjects assigned to be resuscitated with T-Piece
OG001	SIB - Self Inflating Bag With PEEP Valve	Subjects allocated to SIB with PEEP valve
OG002	SIB-Without PEEP Valve	subjects allocate to SIB Without PEEP valve

Units	Counts
Participants	OG000

Secondary

Days on Mechanical Ventilation

Posted

Mean

Standard Deviation

days

after delivery and before four weeks

ID	Title	Description
OG000	T-Piece	Subjects assigned to be resuscitated with T-Piece
OG001	SIB - Self Inflating Bag With PEEP Valve	Subjects allocated to Without PEEP valve
OG002	SIB-Without PEEP Valve	Subjects allocated to SIB-Without PEEP valve

Units	Counts
Participants	OG000

Secondary

Days on CPAP

Posted

Mean

Standard Deviation

days

after birth and during hospitalization up to four weeks

ID	Title	Description
OG000	T-Piece	Subjects assigned to be resuscitated with T-Piece
OG001	SIB - Self Inflating Bag With PEEP Valve	Subjects allocated to Self Inflating Bag with PEEP valve
OG002	SIB-Without PEEP Valve	Subjects allocated to be resuscitated with Self Inflating Bag Without PEEP valve

Units	Counts
Participants	OG000

Secondary

• Incidence of Intracranial Hemorrhage Grades 3-4 for Preterm Newborns <32 Weeks

Incidence of intracranial hemorrhage grades 3-4 for preterm newborns <32 weeks by ultrasound evaluation

this is an analyisis among the subgroup of subjects <32 weeks GA. this is the population at risk of this outcome. It extremely unusual intracranial hemorrhage over 32 weeks GA.

Posted

Count of Participants

Participants

1 day of life and 30 days after birth

ID	Title	Description
OG000	Neopuff TM With PEEP	Newborns ventilated for neonatal resuscitation using Neopuff TM with PEEP T-piece resuscitator Neopuff TM: Positive pressure ventilation will be performed with Neopuff® with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.
OG001	Self Inflating Bag With PEEP	Newborns ventilated for neonatal resuscitation using Self Inflating Bag with PEEP valve attached Self Inflating Bag with PEEP: Positive pressure ventilation will be performed with Self Inflating Bag with PEEP with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.
OG002	Self Inflating Bag Without PEEP

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	T-Piece	Subjects assigned to be resuscitated with T-Piece	11	511	21	511
EG001	SIB - Self Inflating Bag With PEEP	Subjects allocated to be ventilated with Self Inflating Bag with PEEP valve	8	290	25	290
EG002	SIB Without PEEP	Subjects allocated to be ventilated with Self Inflating Bag without PEEP valve	7	226	19	226

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
mortality	General disorders	mortality	Systematic Assessment		EG00011 events11 affected511 at risk EG0018 events8 affected290 at risk EG0027 events7 affected226 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
bronchopulmonary dysplasia	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	BPD defined as need for oxygen at 36 weeks GA	EG00021 events21 affected511 at risk EG00125 events25 affected290 at risk EG00219 events19 affected226 at risk

ID	Term
D011175	Positive-Pressure Respiration

Newborns ventilated for neonatal resuscitationusing Self Inflating Bag without PEEP valve attached

Self Inflating Bag without PEEP: Positive pressure ventilation will be performed with Self Inflating Bag without PEEP with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.

ID	Term
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics
D012138	Respiratory Therapy