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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roberta Ballard; University of California, San Francisco
• Collaborators: Mallinckrodt; ONY
• Treatments: Calfactant; Nitric Oxide; Pulmonary Surfactants

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.