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

Roberta Ballard85 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction)Bronchopulmonary Dysplasia

Interventions

Infasurf (ONY Inc.)DRUG

Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14, if remains intubated.

ShamDRUG

Sham instillation (no treatment) will be given to study infants on days 0, 3, 7, 10, and 14, if remains intubated.

Eligibility

Sex: ALLMin age: 7 DaysMax age: 14 Days

Medical Language ↔ Plain English

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.

Locations (9)

Alta Bates Summit Medical Center

Berkeley, California, United States

Children's Hospital Oakland

Oakland, California, United States

University of California, San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

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.

Time frame: One day after dose

Secondary Outcomes

Alive Without BPD at 36 Weeks Post Menstrual Age

Alive without need for oxygen at 36 weeks post menstrual age.

Time frame: 36 Weeks Post Menstrual Age

Data from ClinicalTrials.gov

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