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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01223274
First received: October 14, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Infant, Newborn
Infant, Low Birth Weight
Infant, Small for Gestational Age
Infant, Premature
Bronchopulmonary Dysplasia
Continuous Positive Airway Pressure
Device: CPAP/PEEP
Device: Standard management practices
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Delivery Room Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) in Extremely Low Birth Weight (ELBW) Infants

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Compliance with the study protocol [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Extent of resuscitation needed [ Time Frame: Until admission to NICU ] [ Designated as safety issue: Yes ]
  • Five minute Apgar [ Time Frame: 5 minutes after birth ] [ Designated as safety issue: Yes ]
  • Total duration of mechanical ventilation [ Time Frame: Until hospital discharge or 120 days of life ] [ Designated as safety issue: Yes ]
  • Proportion of infants requiring surfactant [ Time Frame: 1 day of life ] [ Designated as safety issue: Yes ]
  • Bronchopulmonary dysplasia (BPD) [ Time Frame: 36 weeks of life ] [ Designated as safety issue: Yes ]
  • Number and duration of intubation attempts [ Time Frame: Until admission to the NICU ] [ Designated as safety issue: Yes ]
  • Infants who required positive pressure ventilation for resuscitation in the DR/resuscitation room [ Time Frame: Until admission to the NICU ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: July 2002
Study Completion Date: January 2003
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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).

  Eligibility

Ages Eligible for Study:   up to 10 Minutes
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01223274

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
University of California at San Diego
San Diego, California, United States, 92103-8774
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, North Carolina
RTI International
Durham, North Carolina, United States, 27705
United States, Ohio
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45267
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Investigators
Study Director: Neil N. Finer, MD University of California, San Diego
Principal Investigator: Avroy A. Fanaroff, MD Case Western Reserve University, Rainbow Babies & Children's Hospital
Principal Investigator: Waldemar A. Carlo, MD University of Alabama at Birmingham
Principal Investigator: Edward F. Donovan, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Charles R. Bauer, MD University of Miami
Principal Investigator: W. Kenneth Poole, PhD RTI International
  More Information

Additional Information:
Publications:
Responsible Party: Neil N. Finer, Lead Principal Investigator, University of California - San Diego
ClinicalTrials.gov Identifier: NCT01223274     History of Changes
Other Study ID Numbers: NICHD-NRN-0028, U10HD021364, M01RR000080, U10HD034216, U10HD027853, M01RR008084, U10HD021397, M01RR016587, U10HD040461, U10HD036790
Study First Received: October 14, 2010
Last Updated: October 14, 2010
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
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

Additional relevant MeSH terms:
Birth Weight
Bronchopulmonary Dysplasia
Body Weight
Signs and Symptoms
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on April 14, 2014