Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT)

April 16, 2019 updated by: NICHD Neonatal Research Network

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 Overview

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

Interventional

Enrollment (Actual)

1316

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University
      • San Diego, California, United States, 92103-8774
        • University of California at San Diego
    • Connecticut
      • New Haven, Connecticut, United States, 06504
        • Yale University
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester
    • North Carolina
      • Charlotte, North Carolina, United States, 27157
        • Wake Forest University
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Durham, North Carolina, United States, 27705
        • RTI International
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Cincinnati Children's Medical Center
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University, Rainbow Babies and Children's Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Brown University, Women & Infants Hospital of Rhode Island
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee
    • Texas
      • Dallas, Texas, United States, 75235
        • University of Texas Southwestern Medical Center at Dallas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 6 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Surfactant and Low Oxygen
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Intubation and administration of surfactant by 1 hour of age.
Supplemental oxygen in the range of 85% to 89% until the infant is no longer requiring ventilatory support or oxygen
Other Names:
  • Low oxygen
EXPERIMENTAL: Surfactant and High Oxygen
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturationof 91% to 95%
Intubation and administration of surfactant by 1 hour of age.
Supplemental oxygen in the range of 91% to 95% until the infant is no longer requiring ventilatory support or oxygen.
Other Names:
  • High oxygen
EXPERIMENTAL: CPAP and Low Oxygen
Administration of continuous positive airway pressure (CPAP) and 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 Names:
  • Low oxygen
Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
Other Names:
  • CPAP
EXPERIMENTAL: CPAP and High Oxygen
Administration of continuous positive airway pressure (CPAP)and 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 Names:
  • High oxygen
Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
Other Names:
  • CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival Without Bronchopulmonary Dysplasia (BPD)
Time Frame: 36 weeks
36 weeks
Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery)
Time Frame: 55 weeks
55 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death or Neurodevelopmental Impairment
Time Frame: 18-22 months
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.
Entire NICU stay, up to 120 days
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
From birth through first 7 days of life.
Received Surfactant Treatment
Time Frame: From birth through 120 days of life.
Received any surfactant treatment.
From birth through 120 days of life.
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.
From birth through first 14 days of life.
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.
36 weeks post menstrual age.
Death
Time Frame: 18-22 months
Participants who died by their follow-up visit at 18-22 months.
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.
From birth through first 120 days of life.
Periventricular Leukomalacia (PVL)
Time Frame: From birth through first 120 days of life.
Increased echogenicity or cysts in periventricular region.
From birth through first 120 days of life.
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.
From birth through first 120 days of life.
Endotracheal Intubation
Time Frame: Delivery Room, post-delivery
Insertion of a tube into the trachea to allow positive pressure ventilation for breathing.
Delivery Room, post-delivery
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.
From birth through first 120 days of life.
Pulse Oximetry Values > 90%
Time Frame: From birth through first 120 days of life.
Percentage of time spent above 90% oxygen saturation.
From birth through first 120 days of life.
Blindness in at Least One Eye
Time Frame: 18-22 months
Blindness in at least one eye by 18-22 months of life.
18-22 months
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.
From birth through first 120 days of life.
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.
From birth through first 120 days of life.
Cerebral Palsy
Time Frame: 18-22 months
Incidence of cerebral palsy.
18-22 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 minutes after birth.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (ACTUAL)

February 1, 2009

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

October 3, 2005

First Submitted That Met QC Criteria

October 3, 2005

First Posted (ESTIMATE)

October 5, 2005

Study Record Updates

Last Update Posted (ACTUAL)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • NICHD-NRN-0033
  • M01RR000633 (U.S. NIH Grant/Contract)
  • UL1RR024982 (U.S. NIH Grant/Contract)
  • U10HD036790 (U.S. NIH Grant/Contract)
  • 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)
  • 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)
  • UL1RR024139 (U.S. NIH Grant/Contract)
  • UL1RR024979 (U.S. NIH Grant/Contract)
  • M01RR008084 (U.S. NIH Grant/Contract)
  • M01RR000750 (U.S. NIH Grant/Contract)
  • U10HD021397 (U.S. NIH Grant/Contract)
  • U10HD040461 (U.S. NIH Grant/Contract)
  • U10HD040498 (U.S. NIH Grant/Contract)
  • U10HD040521 (U.S. NIH Grant/Contract)
  • UL1RR025008 (U.S. NIH Grant/Contract)
  • UL1RR024128 (U.S. NIH Grant/Contract)
  • UL1RR024989 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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