Delivery Room CPAP in Extremely Low Birth Weight Infants

Study Overview
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Brief Summary
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This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP and no PEEP if the infant required PPV (the control group).

Detailed Description
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Previous studies suggested that early continuous airway positive pressure (CPAP) may be beneficial in reducing ventilator dependence and subsequent bronchopulmonary dysplasia (BPD) in extremely low birth weight (ELBW) infants. These studies did not test for the optimal timing of CPAP initiation or compare CPAP/PEEP initiation in the delivery room against standard resuscitation methods. Current practice at the time was for the ELBW infant to be intubated early and administered prophylactic surfactant. The feasibility of initiating CPAP in the DR and continuing this therapy without intubation for surfactant had not been determined prospectively in a population of ELBW infants. This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP and no PEEP if the infant required PPV (the control group).

Official Title
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Delivery Room Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) in Extremely Low Birth Weight (ELBW) Infants

Conditions
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Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Bronchopulmonary Dysplasia, Continuous Positive Airway Pressure

Intervention / Treatment
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* Device: CPAP/PEEP
* Device: Standard management practices


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants delivered in a specially equipped resuscitation room(s) <28 weeks gestational age by best obstetric estimate before delivery Requiring resuscitation Exclusion Criteria: No known major congenital anomalies Decision made not to provide full resuscitation

Ages Eligible for Study
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Maximum Age: 10 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP/PEEP Intervention<br>Infants received 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV. | Device: CPAP/PEEP<br>* Infants received 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV.<br>* Other names: Neopuff;|
| Active Comparator: Control<br>Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used. | Device: Standard management practices<br>* Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with the study protocol |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of resuscitation needed |  | Until admission to NICU | 
| Five minute Apgar |  | 5 minutes after birth | 
| Total duration of mechanical ventilation |  | Until hospital discharge or 120 days of life | 
| Proportion of infants requiring surfactant |  | 1 day of life | 
| Bronchopulmonary dysplasia (BPD) |  | 36 weeks of life | 
| Number and duration of intubation attempts |  | Until admission to the NICU | 
| Infants who required positive pressure ventilation for resuscitation in the DR/resuscitation room |  | Until admission to the NICU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Very Low Birth Weight (VLBW), Prematurity, Mechanical ventilation, Positive-Pressure Ventilation, Surfactant, Intubation, Pulse oximetry, Oxygen saturation