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
  Purpose

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.


Condition Intervention Phase
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
Procedure: Continuous Positive Airway Pressure (CPAP)
Procedure: Target oxygen saturation of 85-89%
Procedure: Target oxygen saturation of 91-85%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) in Extremely Low Birth Weight Infants

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1310
Study Start Date: February 2005
Estimated Study Completion Date: April 2016
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Surfactant and Low Oxygen
Early Surfactant and 85-89% target oxygen saturation
Procedure: Early surfactant
Intubation and administration of surfactant by 1 hour of age.
Procedure: Target oxygen saturation of 85-89%
SpO2 range (85% to 89%) until the infant is no longer requiring ventilatory support or oxygen.
Active Comparator: Surfactant and High Oxygen
Early Surfactant and 91-95% target oxygen saturation
Procedure: Early surfactant
Intubation and administration of surfactant by 1 hour of age.
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: CPAP and Low Oxygen
CPAP and 85-89% target oxygen saturation
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.
Active Comparator: CPAP and High Oxygen
CPAP and 91-95% target oxygen saturation
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 91-85%
SpO2 range (91% to 95%) until the infant is no longer requiring ventilatory support or oxygen.

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.

  Eligibility

Ages Eligible for Study:   24 Weeks to 27 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233324

  Show 22 Study Locations
Sponsors and Collaborators
Investigators
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
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00233324     History of Changes
Other Study ID Numbers: 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
Study First Received: October 3, 2005
Last Updated: December 14, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Very Low Birth Weight (VLBW)
Prematurity
Mechanical ventilation
Surfactant
Intubation
Neurodevelopmental impairment
Pulse oximetry
Oxygen saturation
Positive-Pressure Respiration

Additional relevant MeSH terms:
Birth Weight
Bronchopulmonary Dysplasia
Retinal Diseases
Retinopathy of Prematurity
Body Weight
Signs and Symptoms
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Eye Diseases
Pulmonary Surfactants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014