This trial is active, not recruiting.

Conditions surfactant dysfunction, bronchopulmonary dysplasia
Treatments infasurf (ony inc.)
Phase phase 3
Sponsor University of California, San Francisco
Collaborator Bellerophon
Start date January 2008
End date December 2016
Trial size 110 participants
Trial identifier NCT00569530, H10842-31630-01, IND79367


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14.
infasurf (ony inc.) Infasurf
Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14.
(Placebo Comparator)
Infants receiving inhaled nitric oxide will not receive additional doses of Infasurf.
infasurf (ony inc.) Infasurf
Infants will not receive additional doses of Infasurf.

Primary Outcomes

Increased SPB content
time frame: One day after dose

Secondary Outcomes

Assess the effects of late Infasurf treatment on the respiratory status of the ventilated infants receiving inhaled nitric oxide.
time frame: December 2014

Eligibility Criteria

Male or female participants up to 14 days old.

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.

Additional Information

Official title Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
Principal investigator Roberta A Ballard, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by University of California, San Francisco.