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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Exosurf Neonatal and Survanta for the Treatment of Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Death or bronchopulmonary dysplasia [ Time Frame: 28 days of life ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 617
Study Start Date: January 1991
Study Completion Date: January 1992
Primary Completion Date: January 1992 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   up to 6 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01203358

Locations
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
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: Jeffrey D. Horbar/ Lead Principal Investigator, University of Vermont
ClinicalTrials.gov Identifier: NCT01203358     History of Changes
Other Study ID Numbers: NICHD-NRN-0003, U01HD019897, U10HD021364, U10HD021373, U10HD021385, U10HD021397, U10HD021415, U10HD027856, U10HD027853, U10HD027871, U10HD027851, U10HD027880, U10HD027881
Study First Received: September 15, 2010
Last Updated: January 9, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Prematurity
Respiratory distress syndrome
Surfactant

Additional relevant MeSH terms:
Birth Weight
Bronchopulmonary Dysplasia
Respiratory Distress Syndrome, Newborn
Syndrome
Body Weight
Disease
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Ventilator-Induced Lung Injury
Beractant
Pulmonary Surfactants
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014