Bronchopulmonary Dysplasia, Continuous Positive Airway Pressure, Infant, Low Birth Weight, Infant, Newborn, Infant, Premature, Infant, Small for Gestational Age
Conditions
Keywords
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
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).
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).
Interventions
DEVICECPAP/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.
Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used.
Sponsors
NICHD Neonatal Research Network
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compliance with the study protocol | 6 months |
Secondary
| 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 |
Countries
United States
Contacts
STUDY_DIRECTORNeil N. Finer, MD
University of California, San Diego
PRINCIPAL_INVESTIGATORAvroy A. Fanaroff, MD
Case Western Reserve University, Rainbow Babies & Children's Hospital
PRINCIPAL_INVESTIGATORWaldemar A. Carlo, MD
University of Alabama at Birmingham
PRINCIPAL_INVESTIGATOREdward F. Donovan, MD
Children's Hospital Medical Center, Cincinnati
PRINCIPAL_INVESTIGATORCharles R. Bauer, MD
University of Miami
PRINCIPAL_INVESTIGATORW. Kenneth Poole, PhD
RTI International
Outcome results
None listed