Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 85
- Locations
- 9
- Primary Endpoint
- SP-B Content
Study Overview
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 may contribute to the development of bronchopulmonary dysplasia (BPD) in persistently ventilated preterm infants. The investigators 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 7 Days to 14 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Treatment Surfactant (Infasurf) ONY, NY
Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Intervention: Infasurf (ONY Inc.) (Drug)
Sham (no treatment)
Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Intervention: Sham (Drug)
Outcomes
Primary Outcomes
SP-B Content
Time Frame: One day after dose
SP-B Content is the surfactant protein B found in terms of percentage of phospholipid measured one day after surfactant or sham dose.
Secondary Outcomes
- Alive Without BPD at 36 Weeks Post Menstrual Age(36 Weeks Post Menstrual Age)
Investigators
Roberta Ballard
Principal Investigator
University of California, San Francisco