Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00233324
First received: October 3, 2005
Last updated: December 14, 2012
Last verified: October 2012

October 3, 2005
December 14, 2012
February 2005
February 2009   (final data collection date for primary outcome measure)
  • Survival without bronchopulmonary dysplasia (BPD) [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
  • Survival without severe Retinopathy of Prematurity (ROP) (threshold disease or the need for surgery) [ Time Frame: 55 weeks ] [ Designated as safety issue: Yes ]
  • 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
  • Apgar score [ Time Frame: 5 minutes ] [ Designated as safety issue: Yes ]
  • Death or neurodevelopmental impairment [ Time Frame: 18-22 months ] [ Designated as safety issue: Yes ]
  • Duration of mechanical ventilation [ Time Frame: During entire NICU stay ] [ Designated as safety issue: Yes ]
  • Survival without ventilation [ Time Frame: By day 7 ] [ Designated as safety issue: Yes ]
  • Received surfactant treatment [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
  • Incidence of air leaks [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
  • Bronchopulmonary Disease (using the physiologic definition of BPD) [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 18-22 months ] [ Designated as safety issue: Yes ]
  • Severe intraventricular hemorrhage (IVH) [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
  • Periventricular leukomalacia (PVL) [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
  • Threshold ROP requiring surgery [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
  • Endotracheal intubation [ Time Frame: Before 10 minutes of age ] [ Designated as safety issue: Yes ]
  • Duration of oxygen supplementation [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
  • Pulse oximetry values > 90% [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
  • Blindness in at least one eye [ Time Frame: 18-22 months ] [ Designated as safety issue: Yes ]
  • Received postnatal steroids [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
  • Necrotizing enterocolitis (NEC) [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
  • Cerebral palsy [ Time Frame: 18-22 months ] [ Designated as safety issue: Yes ]
  • 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 month
  • use of postnatal steroids
  • the physiologic definition of BPD
  • necrotizing enterocolitis (NEC)
  • IVH and severe IVH
  • periventricular leukomalacia
  • cerebral palsy
Not Provided
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:

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Infant, Newborn
  • Infant, Low Birth Weight
  • Infant, Small for Gestational Age
  • Infant, Premature
  • Bronchopulmonary Dysplasia
  • Retinopathy of Prematurity
  • Continuous Positive Airway Pressure
  • Procedure: Early surfactant
    Intubation and administration of surfactant by 1 hour of age.
  • Procedure: 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
  • Procedure: Target oxygen saturation of 85-89%
    SpO2 range (85% to 89%) until the infant is no longer requiring ventilatory support or oxygen.
  • Procedure: Target oxygen saturation of 91-85%
    SpO2 range (91% to 95%) until the infant is no longer requiring ventilatory support or oxygen.
  • Active Comparator: Surfactant and Low Oxygen
    Early Surfactant and 85-89% target oxygen saturation
    Interventions:
    • Procedure: Early surfactant
    • Procedure: Target oxygen saturation of 85-89%
  • Active Comparator: Surfactant and High Oxygen
    Early Surfactant and 91-95% target oxygen saturation
    Interventions:
    • Procedure: Early surfactant
    • Procedure: Target oxygen saturation of 91-85%
  • Active Comparator: CPAP and Low Oxygen
    CPAP and 85-89% target oxygen saturation
    Interventions:
    • Procedure: Continuous Positive Airway Pressure (CPAP)
    • Procedure: Target oxygen saturation of 85-89%
  • Active Comparator: CPAP and High Oxygen
    CPAP and 91-95% target oxygen saturation
    Interventions:
    • Procedure: Continuous Positive Airway Pressure (CPAP)
    • Procedure: Target oxygen saturation of 91-85%

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1310
April 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
Both
24 Weeks to 27 Weeks
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00233324
NICHD-NRN-0033, U10HD021364, U10HD021373, U10HD021385, U10HD027851, U10HD027853, U10HD027856, U10HD027871, U10HD027880, U10HD027904, U10HD034216, U10HD036790, U10HD040461, U10HD040492, U10HD040689, U10HD053089, U10HD053109, U10HD053119, U10HD053124, UL1RR024128, UL1RR024139, UL1RR024979, UL1RR024982, UL1RR024989, UL1RR025008, M01RR000030, M01RR000633, M01RR000064, M01RR000070, M01RR000750, M01RR000080, M01RR008084, U10HD021397, U10HD040521, U10HD040498
Yes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Center for Research Resources (NCRR)
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 Cincinnati Children's Medical Center
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
October 2012

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