CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 85 enrolled
Drug / intervention
Infasurf (ONY Inc.) +1 moredrug
Likely dose
Infasurf (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/NCT00569530
NCT00569530Phase 3Completed
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Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide

Roberta Ballard·interventional·Posted Dec 7, 2007·Updated May 11, 2021

In Brief

A Phase 3 clinical trial evaluating Infasurf (ONY Inc.) and Sham for Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction) and Bronchopulmonary Dysplasia. Completed, enrolled 85 participants across 9 sites.

Detailed Summary

The purpose of this study is to determine if the combination of late doses of Infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Distress Syndrome of Prematurity (Surfactant Dysfunction), Bronchopulmonary Dysplasia
CountriesUnited States
CollaboratorsMallinckrodt, ONY

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 7, 2007
Enrollment StartJan 1, 2008
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 18.6 years ago

Interventions

Infasurf (ONY Inc.)drug

Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14, if remains intubated.

Shamdrug

Sham instillation (no treatment) will be given to study infants on days 0, 3, 7, 10, and 14, if remains intubated.