Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
NICHD Neonatal Research Network
ClinicalTrials.gov Identifier:
NCT00233324
First received: October 3, 2005
Last updated: July 21, 2015
Last verified: July 2015
  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, Diseases
Other Preterm Infants
Infant, Small for Gestational Age
Premature Birth
Bronchopulmonary Dysplasia
Retinopathy of Prematurity
Drug: Surfactant
Device: Continuous Positive Airway Pressure (CPAP)
Drug: Supplemental oxygen with target saturation of 85 to 89%
Drug: Supplemental oxygen with target saturation of 91 to 95%
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 NICHD Neonatal Research Network:

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:
  • 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 ]

Other Outcome Measures:
  • Apgar Score [ Time Frame: 5 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 1316
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
Experimental: Surfactant and Low Oxygen
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Drug: Surfactant
Intubation and administration of surfactant by 1 hour of age.
Other Name: Surfactant
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
Experimental: Surfactant and High Oxygen
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturationof 91% to 95%
Drug: Surfactant
Intubation and administration of surfactant by 1 hour of age.
Other Name: Surfactant
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: 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)
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
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)
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 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

  Show Detailed Description

  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
NICHD Neonatal Research Network
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: NICHD Neonatal Research Network
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
Results First Received: November 16, 2014
Last Updated: July 21, 2015
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by NICHD Neonatal Research Network:
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:
Infant, Newborn, Diseases
Eye Diseases
Infant, Premature, Diseases
Lung Diseases
Respiratory Tract Diseases
Retinal Diseases
Bronchopulmonary Dysplasia
Premature Birth
Retinopathy of Prematurity
Lung Injury
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications
Ventilator-Induced Lung Injury
Pulmonary Surfactants
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 01, 2015