Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
This trial is active, not recruiting.
|Conditions||surfactant dysfunction, bronchopulmonary dysplasia|
|Treatments||infasurf (ony inc.)|
|Sponsor||University of California, San Francisco|
|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|
|Berkeley, CA||Alta Bates Summit Medical Center||no longer recruiting|
|Oakland, CA||Children's Hospital Oakland||no longer recruiting|
|San Francisco, CA||University of California, San Francisco||no longer recruiting|
|Chicago, IL||Children's Memorial Hospital||no longer recruiting|
|Chicago, IL||Northwestern Memorial Hospital||no longer recruiting|
|Kansas City, MO||Children's Mercy Hospital||no longer recruiting|
|Buffalo, NY||Women and Children's Hospital of Buffalo||no longer recruiting|
|Stony Brook, NY||Stony Brook University Medical Center||no longer recruiting|
|Houston, TX||Texas Children's Hospital||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Increased SPB content
time frame: One day after dose
Assess the effects of late Infasurf treatment on the respiratory status of the ventilated infants receiving inhaled nitric oxide.
time frame: December 2014
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.
|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|
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