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Trial record 5 of 13 for:    "Lung Disease" | "Beractant"

Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome (Surfactant 1)

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ClinicalTrials.gov Identifier: NCT01203358
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : March 22, 2019
Sponsor:
Information provided by:
NICHD Neonatal Research Network

Tracking Information
First Submitted Date  ICMJE September 15, 2010
First Posted Date  ICMJE September 16, 2010
Last Update Posted Date March 22, 2019
Study Start Date  ICMJE January 1991
Actual Primary Completion Date January 1992   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2010)
Death or bronchopulmonary dysplasia [ Time Frame: 28 days of life ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01203358 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2010)
  • Average fraction of inspired oxygen (FIO2) [ Time Frame: 72 hours after treatment ]
  • Mean airway pressure (MAP) [ Time Frame: 72 hours after treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome
Official Title  ICMJE Efficacy and Safety of Exosurf Neonatal and Survanta for the Treatment of Respiratory Distress Syndrome
Brief Summary The purpose of this study is to compare the efficacy of two surfactants, Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome.
Detailed Description The NICHD Neonatal Research Network conducted a randomized trial at 11 centers comparing the efficacy of two surfactants -- Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories) -- for the treatment of neonatal respiratory distress syndrome. Newborn infants with birth weights of 501-1500g with respiratory distress syndrome who were receiving assisted ventilation with 30% oxygen or more within 6 hours of birth were enrolled between January 1991 and January 1992. Infants were randomly assigned to receive up to four intratracheal doses of either Exosurf Neonatal or Survanta.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Infant, Newborn
  • Infant, Low Birth Weight
  • Infant, Small for Gestational Age
  • Infant, Premature
  • Bronchopulmonary Dysplasia
Intervention  ICMJE
  • Drug: Exosurf
    Infants received up to four intratracheal doses of the surfactant.
    Other Name: Exosurf Neonatal (Burroughs Wellcome Co.)
  • Drug: Survanta
    Infants received up to four intratracheal doses of the surfactant.
    Other Name: Survanta (Ross Laboratories)
Study Arms  ICMJE
  • Active Comparator: Surfactant 1
    Exosurf Neonatal (Burroughs Wellcome Co.)
    Intervention: Drug: Exosurf
  • Active Comparator: Surfactant 2
    Survanta (Ross Laboratories)
    Intervention: Drug: Survanta
Publications * Horbar JD, Wright LL, Soll RF, Wright EC, Fanaroff AA, Korones SB, Shankaran S, Oh W, Fletcher BD, Bauer CR, et al. A multicenter randomized trial comparing two surfactants for the treatment of neonatal respiratory distress syndrome. National Institute of Child Health and Human Development Neonatal Research Network. J Pediatr. 1993 Nov;123(5):757-66.

*   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: September 15, 2010)
617
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 1992
Actual Primary Completion Date January 1992   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Newborn infants weighing 501 to 1500 gm with respiratory distress syndrome were receiving assisted ventilation with 30% oxygen or more

Exclusion Criteria:

  • Less than 6 hours of age
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 6 Hours   (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 NCT01203358
Other Study ID Numbers  ICMJE NICHD-NRN-0003
U01HD019897 ( U.S. NIH Grant/Contract )
U10HD021364 ( U.S. NIH Grant/Contract )
U10HD021373 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
U10HD021397 ( U.S. NIH Grant/Contract )
U10HD021415 ( U.S. NIH Grant/Contract )
U10HD027856 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
U10HD027871 ( U.S. NIH Grant/Contract )
U10HD027851 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
U10HD027881 ( 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 Jeffrey D. Horbar/ Lead Principal Investigator, University of Vermont
Study Sponsor  ICMJE NICHD Neonatal Research Network
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jeffrey D. Horbar, MD University of Vermont
Principal Investigator: Elizabeth C. Wright, PhD George Washington University
Principal Investigator: Avroy A. Fanaroff, MD Case Western Reserve University
Principal Investigator: Sheldon B. Korones, MD University of Tennessee
Principal Investigator: Seetha Shankaran, MD Wayne State University
Principal Investigator: Charles R. Bauer, MD University of Miami
Principal Investigator: Jon E. Tyson, MD MPH University of Texas
Principal Investigator: James A. Lemons, MD Indiana University
Principal Investigator: Edward F. Donovan, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Barbara J. Stoll, MD Emory University
Principal Investigator: David K. Stevenson, MD Stanford University
Principal Investigator: LuAnn Papile, MD University of New Mexico
PRS Account NICHD Neonatal Research Network
Verification Date March 2019

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