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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
Information provided by:
NICHD Neonatal Research Network

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.

Condition or disease Intervention/treatment Phase
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Bronchopulmonary Dysplasia Drug: Exosurf Drug: Survanta Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 617 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Exosurf Neonatal and Survanta for the Treatment of Respiratory Distress Syndrome
Study Start Date : January 1991
Actual Primary Completion Date : January 1992
Actual Study Completion Date : January 1992

Arm Intervention/treatment
Active Comparator: Surfactant 1
Exosurf Neonatal (Burroughs Wellcome Co.)
Drug: Exosurf
Infants received up to four intratracheal doses of the surfactant.
Other Name: Exosurf Neonatal (Burroughs Wellcome Co.)

Active Comparator: Surfactant 2
Survanta (Ross Laboratories)
Drug: Survanta
Infants received up to four intratracheal doses of the surfactant.
Other Name: Survanta (Ross Laboratories)

Primary Outcome Measures :
  1. Death or bronchopulmonary dysplasia [ Time Frame: 28 days of life ]

Secondary Outcome Measures :
  1. Average fraction of inspired oxygen (FIO2) [ Time Frame: 72 hours after treatment ]
  2. Mean airway pressure (MAP) [ Time Frame: 72 hours after treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01203358

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United States, California
Stanford University
Palo Alto, California, United States, 94304
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06504
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20052
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30303
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, Ohio
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45267
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Tennessee
University of Tennessee
Memphis, Tennessee, United States, 38163
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
NICHD Neonatal Research Network
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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
Additional Information:
Publications of Results:
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Responsible Party: Jeffrey D. Horbar/ Lead Principal Investigator, University of Vermont
ClinicalTrials.gov Identifier: NCT01203358    
Other Study ID Numbers: 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 )
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Keywords provided by NICHD Neonatal Research Network:
NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Respiratory distress syndrome
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Bronchopulmonary Dysplasia
Birth Weight
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Body Weight
Ventilator-Induced Lung Injury
Lung Injury
Pulmonary Surfactants
Respiratory System Agents