Overview

This trial is active, not recruiting.

Conditions infant, newborn, infant, low birth weight, infant, small for gestational age, infant, premature, bronchopulmonary dysplasia, retinopathy of prematurity, continuous positive airway pressure
Treatments early surfactant, continuous positive airway pressure (cpap), target oxygen saturation of 85-89%, target oxygen saturation of 91-85%
Phase phase 3
Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date February 2005
End date February 2009
Trial size 1310 participants
Trial identifier NCT00233324, M01RR000030, M01RR000064, M01RR000070, M01RR000080, M01RR000633, M01RR000750, M01RR008084, NICHD-NRN-0033, U10HD021364, U10HD021373, U10HD021385, U10HD021397, U10HD027851, U10HD027853, U10HD027856, U10HD027871, U10HD027880, U10HD027904, U10HD034216, U10HD036790, U10HD040461, U10HD040492, U10HD040498, U10HD040521, U10HD040689, U10HD053089, U10HD053109, U10HD053119, U10HD053124, UL1RR024128, UL1RR024139, UL1RR024979, UL1RR024982, UL1RR024989, UL1RR025008

Summary

This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these infants within 2 hours of birth, had a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Early Surfactant and 85-89% target oxygen saturation
early surfactant
Intubation and administration of surfactant by 1 hour of age.
target oxygen saturation of 85-89%
SpO2 range (85% to 89%) until the infant is no longer requiring ventilatory support or oxygen.
(Active Comparator)
Early Surfactant and 91-95% target oxygen saturation
early surfactant
Intubation and administration of surfactant by 1 hour of age.
target oxygen saturation of 91-85%
SpO2 range (91% to 95%) until the infant is no longer requiring ventilatory support or oxygen.
(Active Comparator)
CPAP and 85-89% target oxygen saturation
continuous positive airway pressure (cpap)
Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
target oxygen saturation of 85-89%
SpO2 range (85% to 89%) until the infant is no longer requiring ventilatory support or oxygen.
(Active Comparator)
CPAP and 91-95% target oxygen saturation
continuous positive airway pressure (cpap)
Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
target oxygen saturation of 91-85%
SpO2 range (91% to 95%) until the infant is no longer requiring ventilatory support or oxygen.

Primary Outcomes

Measure
Survival without bronchopulmonary dysplasia (BPD)
time frame: 36 weeks
Survival without severe Retinopathy of Prematurity (ROP) (threshold disease or the need for surgery)
time frame: 55 weeks

Secondary Outcomes

Measure
Apgar score
time frame: 5 minutes
Death or neurodevelopmental impairment
time frame: 18-22 months
Duration of mechanical ventilation
time frame: During entire NICU stay
Survival without ventilation
time frame: By day 7
Received surfactant treatment
time frame: 120 days
Incidence of air leaks
time frame: 120 days
Bronchopulmonary Disease (using the physiologic definition of BPD)
time frame: 36 weeks
Death
time frame: 18-22 months
Severe intraventricular hemorrhage (IVH)
time frame: 120 days
Periventricular leukomalacia (PVL)
time frame: 120 days
Threshold ROP requiring surgery
time frame: 120 days
Endotracheal intubation
time frame: Before 10 minutes of age
Duration of oxygen supplementation
time frame: 120 days
Pulse oximetry values > 90%
time frame: 120 days
Blindness in at least one eye
time frame: 18-22 months
Received postnatal steroids
time frame: 120 days
Necrotizing enterocolitis (NEC)
time frame: 120 days
Cerebral palsy
time frame: 18-22 months

Eligibility Criteria

Male or female participants from 24 weeks up to 27 weeks old.

Inclusion Criteria: - Infants with a minimal gestational age of 24 weeks 0 days to 27 completed weeks (up to 27 6/7ths) by best obstetrical estimate - Infants who will receive full resuscitation as necessary, i.e., no parental request or physician decision to forego resuscitation - Infants whose parents/legal guardians have provided consent for enrollment, or - Infants without known major congenital malformations Exclusion Criteria: - Any infant transported to the center after delivery - Infants whose parents/legal guardians refuse consent - Infants born during a time when the research apparatus/study personnel are not available - Infants < 24 weeks 0 days or > 28 weeks 0 days, completed weeks of gestation

Additional Information

Official title Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) in Extremely Low Birth Weight Infants
Principal investigator Abbot R. Laptook, MD
Description Study subjects were infants of 24 0/7ths to 27 6/7th weeks at birth for which a decision has been made to provide full resuscitation as required. Infants 27 weeks or less gestation (completed weeks by best obstetric estimate) were enrolled because more than 80% of such infants in the Network are intubated, usually early in their neonatal course. The feasibility trial demonstrated that the five NICHD centers involved could reduce intubation in the delivery room to less than 50% of such infants if they are not intubated for surfactant. We excluded infants of 23 weeks or less in view of their extremely high mortality and morbidity, and their almost universal need for delivery room intubation for resuscitation. Secondary studies included: neuroimaging/MRI, growth, and breathing outcomes. Strata: There were two randomization strata, infants of 24 0/7ths to 25 6/7ths weeks, and infants of 26 0/7ths-27 6/7ths weeks by best obstetrical estimate. Randomization: Randomization was stratified by gestational age group, occurred prior to delivery for consented deliveries, and was performed by utilizing specially prepared double-sealed envelopes. Deliveries were randomized as a unit, thus multiples, twins, triplets, etc. were randomized to the same arm of the trial. Informed Consent: Parents were approached prior to delivery for informed consent, and their infants enrolled at delivery. Study Intervention: Mode of Ventilatory Support The intervention began after birth when the infant was given to the resuscitation team. The conduct of the resuscitation followed usual guidelines, and once stabilized, all Control infants in both strata received prophylactic/early surfactant (within one hour of age), whereas all Treatment infants were placed on CPAP/PEEP following stabilization, and were intubated only for resuscitation indications. Pulse Oximeter Allocation: Infants were randomized to receive either a high- or low-saturation of peripheral oxygen (SpO2) as monitored by a study oximeter immediately following NICU admission, with a maximum allowable delay of two hours following admission. The SUPPORT Trial recruitment was temporarily paused on November 23, 2005 based on concern regarding pulse oximeter readings > 95% and due to concern regarding separation of the two arms of the oximetry portion of the study. Further analyses were performed which showed that infants on room air accounted for a significant portion of pulse oximetry saturations above 95%. Separation of the two groups was reanalyzed based on time spent in room air and the duration of time spent at individual SpO2 values, which both showed group differences. The trial was restarted on February 6, 2006. Follow-up: Subjects will be seen for a follow-up visit at 18-22 months corrected age to look at neurodevelopment. Extended follow-up: Subjects enrolled in the Neuroimaging/MRI secondary study will also be seen for a follow-up visit at 6-7 years to look at later school-age development.
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).