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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

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.

Condition or disease Intervention/treatment 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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1316 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) in Extremely Low Birth Weight Infants
Study Start Date : February 2005
Actual Primary Completion Date : February 2009
Actual Study Completion Date : August 2016


Arm Intervention/treatment
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.

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.

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




Primary Outcome Measures :
  1. Survival Without Bronchopulmonary Dysplasia (BPD) [ Time Frame: 36 weeks ]
  2. Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) [ Time Frame: 55 weeks ]

Secondary Outcome Measures :
  1. Death or Neurodevelopmental Impairment [ Time Frame: 18-22 months ]
  2. 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.

  3. 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

  4. Received Surfactant Treatment [ Time Frame: From birth through 120 days of life. ]
    Received any surfactant treatment.

  5. 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.

  6. 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.

  7. Death [ Time Frame: 18-22 months ]
    Participants who died by their follow-up visit at 18-22 months.

  8. 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.

  9. Periventricular Leukomalacia (PVL) [ Time Frame: From birth through first 120 days of life. ]
    Increased echogenicity or cysts in periventricular region.

  10. 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.

  11. Endotracheal Intubation [ Time Frame: Delivery Room, post-delivery ]
    Insertion of a tube into the trachea to allow positive pressure ventilation for breathing.

  12. 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.

  13. Pulse Oximetry Values > 90% [ Time Frame: From birth through first 120 days of life. ]
    Percentage of time spent above 90% oxygen saturation.

  14. Blindness in at Least One Eye [ Time Frame: 18-22 months ]
    Blindness in at least one eye by 18-22 months of life.

  15. 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.

  16. 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.

  17. Cerebral Palsy [ Time Frame: 18-22 months ]
    Incidence of cerebral palsy.


Other Outcome Measures:
  1. 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.



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Layout table for eligibility information
Ages Eligible for Study:   24 Weeks to 27 Weeks   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233324


  Show 22 Study Locations
Sponsors and Collaborators
NICHD Neonatal Research Network
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
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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

Additional Information:
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: NICHD Neonatal Research Network
ClinicalTrials.gov Identifier: NCT00233324     History of Changes
Other Study ID Numbers: 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 )
First Posted: October 5, 2005    Key Record Dates
Results First Posted: December 5, 2014
Last Update Posted: April 18, 2019
Last Verified: April 2019
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:
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Bronchopulmonary Dysplasia
Retinopathy of Prematurity
Premature Birth
Infant, Newborn, Diseases
Birth Weight
Retinal Diseases
Eye Diseases
Body Weight
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Pulmonary Surfactants
Respiratory System Agents