Brief Title
Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
Official Title
Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
Brief 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.
Detailed Description
Surfactant dysfunction my contribute to the development of bronchopulmonary dysplasia (BPD) in persistently ventilated preterm infants. We conducted a multi-center, randomized, blinded pilot study to assess the safety and efficacy of late administration of surfactant (Calfactant - high in protein B) in combination with prolonged inhaled nitric oxide in preterm infants < 1000 grams birthweight (BW). Calfactant is one of several types of exogenous surfactant. Calfactant has the highest % of surfactant protein B of the different types.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
SP-B Content
Secondary Outcome
Alive Without BPD at 36 Weeks Post Menstrual Age
Condition
Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction)
Intervention
Infasurf (ONY Inc.)
Study Arms / Comparison Groups
Treatment Surfactant (Infasurf) ONY, NY
Description: Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
85
Start Date
January 2008
Completion Date
December 2012
Primary Completion Date
December 2012
Eligibility 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.
Gender
All
Ages
N/A - 14 Days
Accepts Healthy Volunteers
No
Contacts
Roberta A Ballard, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00569530
Organization ID
H10842-31630-01
Secondary IDs
IND79367
Responsible Party
Principal Investigator
Study Sponsor
University of California, San Francisco
Collaborators
Mallinckrodt
Study Sponsor
Roberta A Ballard, MD, Principal Investigator, University of California, San Francisco
Verification Date
May 2016