Delivery Room CPAP in Extremely Low Birth Weight Infants

Bronchopulmonary Dysplasia Clinical Trial

— DR-CPAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223274
• Other study ID #: NICHD-NRN-0028
• Secondary ID: U10HD021364M01RR
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 14, 2010
• Last updated: September 22, 2017
• Start date: July 2002
• Est. completion date: January 2003

Study information

• Verified date: September 2017
• Source: NICHD Neonatal Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 2003
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Minutes

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Cincinnati Children's Medical Center	Cincinnati	Ohio
United States	Case Western Reserve University, Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	RTI International	Durham	North Carolina
United States	University of Miami	Miami	Florida
United States	University of California at San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
NICHD Neonatal Research Network	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 i — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance with the study protocol		6 months
Secondary	Extent of resuscitation needed		Until admission to NICU
Secondary	Five minute Apgar		5 minutes after birth
Secondary	Total duration of mechanical ventilation		Until hospital discharge or 120 days of life
Secondary	Proportion of infants requiring surfactant		1 day of life
Secondary	Bronchopulmonary dysplasia (BPD)		36 weeks of life
Secondary	Number and duration of intubation attempts		Until admission to the NICU
Secondary	Infants who required positive pressure ventilation for resuscitation in the DR/resuscitation room		Until admission to the NICU

External Links

•   NICHD Neonatal Research Network