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

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01203358
First received: September 15, 2010
Last updated: January 9, 2011
Last verified: September 2010

September 15, 2010
January 9, 2011
January 1991
January 1992   (final data collection date for primary outcome measure)
Death or bronchopulmonary dysplasia [ Time Frame: 28 days of life ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01203358 on ClinicalTrials.gov Archive Site
  • Average fraction of inspired oxygen (FIO2) [ Time Frame: 72 hours after treatment ] [ Designated as safety issue: Yes ]
  • Mean airway pressure (MAP) [ Time Frame: 72 hours after treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome
Efficacy and Safety of Exosurf Neonatal and Survanta for the Treatment of Respiratory Distress Syndrome

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Infant, Newborn
  • Infant, Low Birth Weight
  • Infant, Small for Gestational Age
  • Infant, Premature
  • Bronchopulmonary Dysplasia
  • 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)
  • Active Comparator: Surfactant 1
    Exosurf Neonatal (Burroughs Wellcome Co.)
    Intervention: Drug: Exosurf
  • Active Comparator: Surfactant 2
    Survanta (Ross Laboratories)
    Intervention: Drug: Survanta
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.
 
Completed
617
January 1992
January 1992   (final data collection date for primary outcome measure)

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
Both
up to 6 Hours
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01203358
NICHD-NRN-0003, U01HD019897, U10HD021364, U10HD021373, U10HD021385, U10HD021397, U10HD021415, U10HD027856, U10HD027853, U10HD027871, U10HD027851, U10HD027880, U10HD027881
Yes
Jeffrey D. Horbar/ Lead Principal Investigator, University of Vermont
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
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 Cincinnati Children's Medical Center
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
September 2010

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