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