NCT00000570

Brief Summary

To determine if surfactant administration at birth in infants at high risk for respiratory distress syndrome (RDS) modified the clinical course of the syndrome.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 1986

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1986

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1990

Completed
9.4 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

December 13, 2013

Status Verified

January 1, 2000

First QC Date

October 27, 1999

Last Update Submit

December 12, 2013

Conditions

Interventions

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Boy and girl preterm infants 24-29 weeks of gestational age and 500-1400 grams birthweight.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Hallman M, Merritt TA, Bry K, Berry C. Association between neonatal care practices and efficacy of exogenous human surfactant: results of a bicenter randomized trial. Pediatrics. 1993 Mar;91(3):552-60.

    PMID: 8441558BACKGROUND

MeSH Terms

Conditions

Lung DiseasesRespiratory Distress Syndrome

Interventions

Pulmonary Surfactants

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Respiratory System AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Thurman Merritt

    University of California, San Diego

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

January 1, 1986

Study Completion

June 1, 1990

Last Updated

December 13, 2013

Record last verified: 2000-01