CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 511 enrolled
Drug / intervention
Infasurf surfactant (ONY, Inc.) +1 moredrug
Likely dose
Infasurf surfactant (ONY, Inc.) 3mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01022580
NCT01022580Phase 3Completed
CompareCT.gov

Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia: A Study in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide

Roberta Ballard·interventional·Posted Dec 1, 2009·Updated May 13, 2021

In Brief

A Phase 3 clinical trial evaluating Infasurf surfactant (ONY, Inc.) and Sham (No Treatment) for Bronchopulmonary Dysplasia. Completed, enrolled 511 participants across 21 sites.

Detailed Summary

The purpose of this study is to determine if late doses of Infasurf surfactant given when patients are receiving inhaled nitric oxide will interact to improve surfactant function and increase survival without BPD in treated infants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBronchopulmonary Dysplasia
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 1, 2009
Enrollment StartJan 1, 2010
Primary CompletionDec 1, 2013
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 16.6 years ago

Interventions

Infasurf surfactant (ONY, Inc.)drug

Late doses of Infasurf 3ml/kg will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated.

Sham (No Treatment)drug

Late doses of Sham (No treatment) will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated.