Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome

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Brief Title

Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome

Official Title

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 Phase

Phase 2/Phase 3

Study Type

Interventional

Primary Outcome

Death or bronchopulmonary dysplasia

Secondary Outcome

 Average fraction of inspired oxygen (FIO2)

Condition

Infant, Newborn

Intervention

Exosurf

Study Arms / Comparison Groups

 Surfactant 1
Description:  Exosurf Neonatal (Burroughs Wellcome Co.)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

617

Start Date

January 1991

Completion Date

January 1992

Primary Completion Date

January 1992

Eligibility 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

Gender

All

Ages

N/A - 6 Hours

Accepts Healthy Volunteers

No

Contacts

Jeffrey D. Horbar, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01203358

Organization ID

NICHD-NRN-0003

Secondary IDs

U01HD019897

Study Sponsor

NICHD Neonatal Research Network

Study Sponsor

Jeffrey D. Horbar, MD, Study Director, University of Vermont

Verification Date

March 2019