Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Roberta Ballard; University of California, San Francisco
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Calfactant; Nitric Oxide; Pulmonary Surfactants

Criteria

Inclusion Criteria:

• <=28 0/7 weeks gestational age

• Day of life 7-14

• Intubated and mechanically ventilated

• Plan to treat with inhaled nitric oxide

Exclusion Criteria:

• Serious congenital malformations or chromosomal abnormalities

• Life expectancy <7 days from enrollment

• Clinically unstable

• Less tha 48 hours since last dose surfactant

• Ability to obtain 36 week primary outcome information is unlikely