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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 : April 18, 2019
Sponsor:
Collaborators:
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)
Information provided by (Responsible Party):
NICHD Neonatal Research Network

Tracking Information
First Submitted Date  ICMJE October 3, 2005
First Posted Date  ICMJE October 5, 2005
Results First Submitted Date  ICMJE November 16, 2014
Results First Posted Date  ICMJE December 5, 2014
Last Update Posted Date April 18, 2019
Study Start Date  ICMJE February 2005
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2005)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • Death or Neurodevelopmental Impairment [ Time Frame: 18-22 months ]
  • Duration of Mechanical Ventilation [ Time Frame: Entire NICU stay, up to 120 days ]
    The length in days that an individual was on mechanical ventilation which includes high frequency and conventional ventilation.
  • Survival Without Ventilation [ Time Frame: From birth through first 7 days of life. ]
    Surviving the first 7 days of life without any need for ventilation by day 7
  • Received Surfactant Treatment [ Time Frame: From birth through 120 days of life. ]
    Received any surfactant treatment.
  • Number of Participants With Air Leaks [ Time Frame: From birth through first 14 days of life. ]
    Number of participants with air leaks including pnemothorax, pulmonary interstitial emphysema (PIE), and pneumopericardium.
  • Physiological Bronchopulmonary Dysplasia [ Time Frame: 36 weeks post menstrual age. ]
    Infants who received support via ventilator or CPAP at 36 weeks PMA. Alternatively, infants who received low levels of supplemental oxygen (<30%) at 36 weeks PMA may have been eligible for a physiologic challenge in which there was an attempt to wean the infant to room air. Specifically, infants were eligible for the challenge if at 36 weeks PMA if they were receiving effective oxygen <27% and had majority saturation >90%, or they were receiving effective oxygen 27-30% and had majority saturation >96%, or they were receiving room air by nasal cannula. The challenge took place between 36 and 37 weeks PMA. Those who were not challenged because their level of support increased (support with CPAP or ventilation or increased oxygen) were considered to have BPD, as were those who failed the challenge.
  • Death [ Time Frame: 18-22 months ]
    Participants who died by their follow-up visit at 18-22 months.
  • Severe Intraventricular Hemorrhage (IVH) [ Time Frame: From birth through first 120 days of life. ]
    There are four grades of intraventricular hemorrhage: Grade I - echodensity/hemorrhage is confied to the germinal matrix. Grade II - echodensity/hemorrhage in the lateral ventricle(s) without distention. Grade III - echodensity/hemorrhage in the lateral ventricle(s) with distention. Grade IV - echodense lesion in the parenchyma. Severe IVH is defined as having IVH grades of III or IV.
  • Periventricular Leukomalacia (PVL) [ Time Frame: From birth through first 120 days of life. ]
    Increased echogenicity or cysts in periventricular region.
  • Threshold Retinopathy of Prematurity (ROP) Requiring Surgery [ Time Frame: From birth through first 120 days of life. ]
    Diagnosis of retinopathy of prematurity which resulted in requiring surgery.
  • Endotracheal Intubation [ Time Frame: Delivery Room, post-delivery ]
    Insertion of a tube into the trachea to allow positive pressure ventilation for breathing.
  • Duration of Oxygen Supplementation [ Time Frame: From birth through first 120 days of life. ]
    The length of time in days that a participant had oxygen supplementation.
  • Pulse Oximetry Values > 90% [ Time Frame: From birth through first 120 days of life. ]
    Percentage of time spent above 90% oxygen saturation.
  • Blindness in at Least One Eye [ Time Frame: 18-22 months ]
    Blindness in at least one eye by 18-22 months of life.
  • Received Postnatal Steroids [ Time Frame: From birth through first 120 days of life. ]
    Participant received any doses or courses of systemic steroids to prevent or treat bronchopulmonary dysplasia/chronic lung disease.
  • Necrotizing Enterocolitis (NEC) [ Time Frame: From birth through first 120 days of life. ]
    Proven necrotizing enterocolitis (NEC) diagnosis using the Modified Bell's Staging Criteria for NEC.
  • Cerebral Palsy [ Time Frame: 18-22 months ]
    Incidence of cerebral palsy.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2005)
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: April 16, 2019)
Apgar Scores at 5 Minutes [ Time Frame: 5 minutes after birth. ]
Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration" and scores range from 1 (worst) to 10 (best) indicating a baby's condition 5 minutes after birth.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surfactant Positive Airway Pressure and Pulse Oximetry Trial
Official Title  ICMJE Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) in Extremely Low Birth Weight Infants
Brief 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.
Detailed 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. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Infant, Newborn, Diseases
  • Other Preterm Infants
  • Infant, Small for Gestational Age
  • Premature Birth
  • Bronchopulmonary Dysplasia
  • Retinopathy of Prematurity
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Surfactant and Low Oxygen
    Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
    Interventions:
    • 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%
    Interventions:
    • 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%
    Interventions:
    • 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%
    Interventions:
    • Device: Continuous Positive Airway Pressure (CPAP)
    • Drug: Supplemental oxygen with target saturation of 91 to 95%
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 28, 2014)
1316
Original Enrollment  ICMJE
 (submitted: October 3, 2005)
1320
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 24 Weeks to 27 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00233324
Other Study ID Numbers  ICMJE NICHD-NRN-0033
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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NICHD Neonatal Research Network
Study Sponsor  ICMJE NICHD Neonatal Research Network
Collaborators  ICMJE
  • 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)
Investigators  ICMJE
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
PRS Account NICHD Neonatal Research Network
Verification Date April 2019

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