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

March 20, 2019 updated by: NICHD Neonatal Research Network

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

617

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University
    • Connecticut
      • New Haven, Connecticut, United States, 06504
        • Yale University
    • District of Columbia
      • Washington, District of Columbia, United States, 20052
        • George Washington University
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Cincinnati Children's Medical Center
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University, Rainbow Babies and Children's Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee
    • Texas
      • Dallas, Texas, United States, 75235
        • University Of Texas Southwestern Medical Center At Dallas
    • Vermont
      • Burlington, Vermont, United States, 05405
        • University of Vermont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 hours (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Survanta (Ross Laboratories)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death or bronchopulmonary dysplasia
Time Frame: 28 days of life
28 days of life

Secondary Outcome Measures

Outcome Measure
Time Frame
Average fraction of inspired oxygen (FIO2)
Time Frame: 72 hours after treatment
72 hours after treatment
Mean airway pressure (MAP)
Time Frame: 72 hours after treatment
72 hours after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NICHD Neonatal Research Network

Investigators

  • Study Director: Jeffrey D. Horbar, MD, University of Vermont
  • Principal Investigator: LuAnn Papile, MD, University of New Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1991

Primary Completion (ACTUAL)

January 1, 1992

Study Completion (ACTUAL)

January 1, 1992

Study Registration Dates

First Submitted

September 15, 2010

First Submitted That Met QC Criteria

September 15, 2010

First Posted (ESTIMATE)

September 16, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NICHD-NRN-0003
  • 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)
  • U01HD019897 (U.S. NIH Grant/Contract)
  • U10HD021415 (U.S. NIH Grant/Contract)
  • U10HD027881 (U.S. NIH Grant/Contract)
  • U10HD021397 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bronchopulmonary Dysplasia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe