Delivery Room CPAP in Extremely Low Birth Weight Infants

Summary

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).

Conditions

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

Interventions

DEVICE

CPAP/PEEP

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

Standard management practices

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

Sponsors & Collaborators

• National Center for Research Resources (NCRR)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Neil N. Finer, MD · University of California, San Diego

• Avroy A. Fanaroff, MD · Case Western Reserve University, Rainbow Babies & Children's Hospital

• Waldemar A. Carlo, MD · University of Alabama at Birmingham

• Edward F. Donovan, MD · Children's Hospital Medical Center, Cincinnati

• Charles R. Bauer, MD · University of Miami

• W. Kenneth Poole, PhD · RTI International

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

10 Minutes

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-07-31

Primary Completion

2003-01-31

Completion

2003-01-31

Countries

• United States

Study Locations