Trial | NCT01203358  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    617
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.
Study Started
Jan 31
1991
Primary Completion
Jan 31
1992
Study Completion
Jan 31
1992
Last Update
Mar 22
2019

Drug Exosurf

Infants received up to four intratracheal doses of the surfactant.

  • Other names: Exosurf Neonatal (Burroughs Wellcome Co.)

Drug Survanta

Infants received up to four intratracheal doses of the surfactant.

  • Other names: Survanta (Ross Laboratories)

Surfactant 1 Active Comparator

Exosurf Neonatal (Burroughs Wellcome Co.)

Surfactant 2 Active Comparator

Survanta (Ross Laboratories)

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
No Results Posted