Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide

Study Overview
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Brief Summary
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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
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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.

Official Title
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Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide

Conditions
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Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction), Bronchopulmonary Dysplasia

Intervention / Treatment
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* Drug: Infasurf (ONY Inc.)
* Drug: Sham


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Surfactant (Infasurf) ONY, NY<br>Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated. | Drug: Infasurf (ONY Inc.)<br>* Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14, if remains intubated.<br>* Other names: Infasurf;|
| Placebo Comparator: Sham (no treatment)<br>Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated. | Drug: Sham<br>* Sham instillation (no treatment) will be given to study infants on days 0, 3, 7, 10, and 14, if remains intubated.<br>* Other names: Air;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SP-B Content | SP-B Content is the surfactant protein B found in terms of percentage of phospholipid measured one day after surfactant or sham dose. | One day after dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alive Without BPD at 36 Weeks Post Menstrual Age | Alive without need for oxygen at 36 weeks post menstrual age. | 36 Weeks Post Menstrual Age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nitric oxide, surfactant, bronchopulmonary dysplasia, prematurity, neonates, iNO, Infasurf, lung function, ventilated infants