Clinical trial NCT01223274: Delivery Room CPAP in Extremely Low Birth Weight Infants
Official title: Delivery Room Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) in Extremely Low Birth Weight (ELBW) Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Infant, Newborn
Infant, Low Birth Weight
Infant, Small for Gestational Age
Infant, Premature
Bronchopulmonary Dysplasia
Continuous Positive Airway Pressure
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
Lead sponsor: NICHD Neonatal Research Network
Sponsor class: NETWORK
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2010-10-18
Enrollment: 104
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Compliance with the study protocol
timeFrame: 6 months
Secondary outcomes:
measure: Extent of resuscitation needed
timeFrame: Until admission to NICU
measure: Five minute Apgar
timeFrame: 5 minutes after birth
measure: Total duration of mechanical ventilation
timeFrame: Until hospital discharge or 120 days of life
measure: Proportion of infants requiring surfactant
timeFrame: 1 day of life
measure: Bronchopulmonary dysplasia (BPD)
timeFrame: 36 weeks of life
measure: Number and duration of intubation attempts
timeFrame: Until admission to the NICU
measure: Infants who required positive pressure ventilation for resuscitation in the DR/resuscitation room
timeFrame: Until admission to the NICU
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Diego
country: United States
facility: University of California at San Diego
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Durham
country: United States
facility: RTI International
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University, Rainbow Babies and Children's Hospital
state: Ohio
Study officials:
affiliation: University of California, San Diego
name: Neil N. Finer, MD
role: STUDY_DIRECTOR
affiliation: Case Western Reserve University, Rainbow Babies & Children's Hospital
name: Avroy A. Fanaroff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Waldemar A. Carlo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Edward F. Donovan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Charles R. Bauer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: RTI International
name: W. Kenneth Poole, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.