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

Delivery Room Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) in Extremely Low Birth Weight (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).

Study Overview

• Status: Completed
• Conditions: Bronchopulmonary Dysplasia; Continuous Positive Airway Pressure; Infant, Small for Gestational Age; Infant, Premature; Infant, Low Birth Weight; Infant, Newborn
• Intervention / Treatment: Device: CPAP/PEEP; Device: Standard management practices

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • California
    • San Diego, California, United States, 92103-8774
      • University of California at San Diego
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • RTI International
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Cincinnati Children's Medical Center
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University, Rainbow Babies and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CPAP/PEEP Intervention; 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; 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.; Other Names: Neopuff
Active Comparator: Control; Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used.	Device: Standard management practices; Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compliance with the study protocol	6 months

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: NICHD Neonatal Research Network
• Collaborators: National Center for Research Resources (NCRR)
• Investigators: Study Director: Neil N. Finer, MD, University of California, San Diego

Publications and helpful links

General Publications

• Finer NN, Carlo WA, Duara S, Fanaroff AA, Donovan EF, Wright LL, Kandefer S, Poole WK; National Institute of Child Health and Human Development Neonatal Research Network. Delivery room continuous positive airway pressure/positive end-expiratory pressure in extremely low birth weight infants: a feasibility trial. Pediatrics. 2004 Sep;114(3):651-7. doi: 10.1542/peds.2004-0394.

Helpful Links

• NICHD Neonatal Research Network

Study record dates

Study Major Dates

• Study Start: July 1, 2002
• Primary Completion (Actual): January 1, 2003
• Study Completion (Actual): January 1, 2003

Study Registration Dates

• First Submitted: October 14, 2010
• First Submitted That Met QC Criteria: October 14, 2010
• First Posted (Estimate): October 18, 2010

Study Record Updates

• Last Update Posted (Actual): September 26, 2017
• Last Update Submitted That Met QC Criteria: September 22, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Prematurity; Intubation; Surfactant; Mechanical ventilation; Oxygen saturation; Pulse oximetry; NICHD Neonatal Research Network; Very Low Birth Weight (VLBW); Extremely Low Birth Weight (ELBW); Positive-Pressure Ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Body Weight; Birth Weight; Bronchopulmonary Dysplasia
• Other Study ID Numbers: NICHD-NRN-0028; U10HD036790 (U.S. NIH Grant/Contract); U10HD021364 (U.S. NIH Grant/Contract); U10HD027853 (U.S. NIH Grant/Contract); U10HD034216 (U.S. NIH Grant/Contract); M01RR008084 (U.S. NIH Grant/Contract); U10HD021397 (U.S. NIH Grant/Contract); U10HD040461 (U.S. NIH Grant/Contract); M01RR000080 (U.S. NIH Grant/Contract); M01RR016587 (U.S. NIH Grant/Contract)