Delivery Room CPAP in Extremely Low Birth Weight Infants (DR-CPAP)

NICHD Neonatal Research Network

Status and phase: Completed; Phase 2; Phase 1

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

Treatments: Device: Standard management practices; Device: CPAP/PEEP

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT01223274

U10HD036790 (U.S. NIH Grant/Contract)

M01RR016587 (U.S. NIH Grant/Contract)

M01RR000080 (U.S. NIH Grant/Contract)

U10HD027853 (U.S. NIH Grant/Contract)

U10HD021397 (U.S. NIH Grant/Contract)

NICHD-NRN-0028

U10HD021364 (U.S. NIH Grant/Contract)

M01RR008084 (U.S. NIH Grant/Contract)

U10HD034216 (U.S. NIH Grant/Contract)

U10HD040461 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 104 patients

Sex: All

Ages: Under 10 minutes old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

104 participants in 2 patient groups

CPAP/PEEP Intervention

Experimental group

Description:

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.

Treatment:

Device: CPAP/PEEP

Control

Active Comparator group

Description:

Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used.

Treatment:

Device: Standard management practices