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Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT)

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ClinicalTrials.gov Identifier: NCT00233324
Recruitment Status : Completed
First Posted : October 5, 2005
Results First Posted : December 5, 2014
Last Update Posted : October 25, 2017
Information provided by (Responsible Party):

October 3, 2005
October 5, 2005
November 16, 2014
December 5, 2014
October 25, 2017
February 2005
February 2009   (Final data collection date for primary outcome 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 ]
  • 1. survival without BPD at 36 weeks
  • 2. survival without the occurrence of threshold ROP and/or the need for surgical intervention
  • 3. Mortality/Neurodevelopmental outcome at 18-22 months corrected age
Complete list of historical versions of study NCT00233324 on ClinicalTrials.gov Archive Site
  • 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 ]
  • endotracheal intubation before 10 minutes of age
  • Duration of Mechanical Ventilation
  • surfactant treatment
  • air leaks
  • intubation
  • Duration of Oxygen Supplementation
  • oximetry values > 90%
  • blindness of at least one eye at 18-22 months
  • use of postnatal steroids
  • the physiologic definition of BPD
  • Necrotizing Enterocolitis (NEC)
  • IVH and severe IVH
  • periventricular leukomalacia
  • Cerebral Palsy
Apgar Score [ Time Frame: 5 minutes ]
Not Provided
Surfactant Positive Airway Pressure and Pulse Oximetry Trial
Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) in Extremely Low Birth Weight Infants
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.

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 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. Subjects attending the 6-7 year follow-up visit will be invited to participate in this secondary study which will analyze the relationship of salivary cortisol and dehydroepiandrosterone (DHEA) to: (a) blood pressure and adiposity; (b) prenatal and postnatal growth; and (c) DNA methylation patterns.

Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Infant, Newborn, Diseases
  • Other Preterm Infants
  • Infant, Small for Gestational Age
  • Premature Birth
  • Bronchopulmonary Dysplasia
  • Retinopathy of Prematurity
  • Drug: Surfactant
    Intubation and administration of surfactant by 1 hour of age.
  • Device: 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
    Other Name: CPAP
  • Drug: Supplemental oxygen with target saturation of 85 to 89%
    Supplemental oxygen in the range of 85% to 89% until the infant is no longer requiring ventilatory support or oxygen
    Other Name: Low oxygen
  • Drug: Supplemental oxygen with target saturation of 91 to 95%
    Supplemental oxygen in the range of 91% to 95% until the infant is no longer requiring ventilatory support or oxygen.
    Other Name: High oxygen
  • Experimental: Surfactant and Low Oxygen
    Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
    • Drug: Surfactant
    • Drug: Supplemental oxygen with target saturation of 85 to 89%
  • Experimental: Surfactant and High Oxygen
    Administration of surfactant by endotracheal tube and supplemental oxygen with target saturationof 91% to 95%
    • Drug: Surfactant
    • Drug: Supplemental oxygen with target saturation of 91 to 95%
  • Experimental: CPAP and Low Oxygen
    Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
    • Device: Continuous Positive Airway Pressure (CPAP)
    • Drug: Supplemental oxygen with target saturation of 85 to 89%
  • Experimental: CPAP and High Oxygen
    Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
    • Device: Continuous Positive Airway Pressure (CPAP)
    • Drug: Supplemental oxygen with target saturation of 91 to 95%

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
August 2016
February 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
24 Weeks to 27 Weeks   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
U10HD021364 ( U.S. NIH Grant/Contract )
U10HD021373 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
U10HD027851 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
U10HD027856 ( U.S. NIH Grant/Contract )
U10HD027871 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
U10HD027904 ( U.S. NIH Grant/Contract )
U10HD034216 ( U.S. NIH Grant/Contract )
U10HD036790 ( U.S. NIH Grant/Contract )
U10HD040461 ( U.S. NIH Grant/Contract )
U10HD040492 ( U.S. NIH Grant/Contract )
U10HD040689 ( U.S. NIH Grant/Contract )
U10HD053089 ( U.S. NIH Grant/Contract )
U10HD053109 ( U.S. NIH Grant/Contract )
U10HD053119 ( U.S. NIH Grant/Contract )
U10HD053124 ( U.S. NIH Grant/Contract )
UL1RR024128 ( U.S. NIH Grant/Contract )
UL1RR024139 ( U.S. NIH Grant/Contract )
UL1RR024979 ( U.S. NIH Grant/Contract )
UL1RR024982 ( U.S. NIH Grant/Contract )
UL1RR024989 ( U.S. NIH Grant/Contract )
UL1RR025008 ( U.S. NIH Grant/Contract )
M01RR000633 ( U.S. NIH Grant/Contract )
M01RR000750 ( U.S. NIH Grant/Contract )
M01RR008084 ( U.S. NIH Grant/Contract )
U10HD021397 ( U.S. NIH Grant/Contract )
U10HD040521 ( U.S. NIH Grant/Contract )
U10HD040498 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
NICHD Neonatal Research Network
NICHD Neonatal Research Network
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Center for Research Resources (NCRR)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Abbot R. Laptook, MD Brown University, Women & Infants Hospital of Rhode Island
Principal Investigator: Michele C. Walsh, MD MS Case Western Reserve University, Rainbow Babies and Children's Hospital
Principal Investigator: Ronald N. Goldberg, MD Duke University
Principal Investigator: Barbara J. Stoll, MD Emory University
Principal Investigator: Brenda B. Poindexter, MD MS Indiana University
Principal Investigator: Abhik Das, PhD RTI International
Principal Investigator: Krisa P. Van Meurs, MD Stanford University
Principal Investigator: Ivan D. Frantz III, MD Tufts Medical Center
Principal Investigator: Neil N. Finer, MD University of California, San Diego
Principal Investigator: Kurt Schibler, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Waldemar A. Carlo, MD University of Alabama at Birmingham
Principal Investigator: Edward F. Bell, MD University of Iowa
Principal Investigator: Kristi L. Watterberg, MD University of New Mexico
Principal Investigator: Pablo J. Sanchez, MD University of Texas, Southwestern Medical Center at Dallas
Principal Investigator: Kathleen A. Kennedy, MD MPH The University of Texas Health Science Center, Houston
Principal Investigator: Roger G. Faix, MD University of Utah
Principal Investigator: Seetha Shankaran, MD Wayne State University
Principal Investigator: Richard A. Ehrenkranz, MD Yale University
NICHD Neonatal Research Network
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP