DR-CPAP: Delivery Room CPAP in Extremely Low Birth Weight Infants

Sponsor

NICHD Neonatal Research Network (Other)

Overall Status

Completed

CT.gov ID

NCT01223274

Collaborator

National Center for Research Resources (NCRR) (NIH)

104

Enrollment

Locations

Arms

Duration (Months)

17.3

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2002

Actual Primary Completion Date :

Jan 1, 2003

Actual Study Completion Date :

Jan 1, 2003

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

Compliance with the study protocol [6 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 10 Minutes

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	University of California at San Diego	San Diego	California	United States	92103-8774
3	University of Miami	Miami	Florida	United States	33136
4	RTI International	Durham	North Carolina	United States	27705
5	Cincinnati Children's Medical Center	Cincinnati	Ohio	United States	45267
6	Case Western Reserve University, Rainbow Babies and Children's Hospital	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

NICHD Neonatal Research Network
National Center for Research Resources (NCRR)

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