Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-31 @ 11:58 AM
Study NCT ID:
NCT01203358
Status:
COMPLETED
Last Update Posted:
2019-03-22
First Post:
2010-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome
Sponsor:
NICHD Neonatal Research Network
Organization:
Study Overview
Official Title:
Efficacy and Safety of Exosurf Neonatal and Survanta for the Treatment of Respiratory Distress Syndrome
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Surfactant 1
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01HD019897 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD021364 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD021373 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD021385 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD021397 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD021415 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD027856 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD027853 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD027871 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD027851 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD027880 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD027881 | NIH | None | https://reporter.nih.gov/quic… | View |