Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide

Completed · Phase 3 · Has a placebo group

Conditions studied: Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction), Bronchopulmonary Dysplasia

In brief

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.

Key facts

Study ID

NCT00569530

Run by

Roberta Ballard

People needed

85

Starts

2008-01-01

Expected to finish

2012-12-01

Last updated by the study team

2021-05-11

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Less than or equal to 1000 gm. birth weight
• Less than or equal to 30 weeks gestational age
• Day 7-14 of life
• Intubated and mechanically ventilated at any time days 7-14 of life

You may not qualify if…

• Serious congenital malformations
• Life expectancy less than 7 days from enrollment
• Previous treatment with iNO
• Active pulmonary hemorrhage at time of enrollment
• Active air leak syndrome at time of enrollment
• Bilateral grade IV intracranial hemorrhage prior to enrollment
• Less than 48 hours from last clinical dose of early surfactant.

Where it is running

• Alta Bates Summit Medical Center — Berkeley, California, United States
• Children's Hospital Oakland — Oakland, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Women and Children's Hospital of Buffalo — Buffalo, New York, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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