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

Phase 3

Completed

• Conditions: Bronchopulmonary Dysplasia; Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction)
• Interventions: Drug: Sham; Drug: Infasurf (ONY Inc.)

• Registration Number: NCT00569530
• Lead Sponsor: Roberta Ballard

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 Timeline

• Study First Submitted: 2007-12-05
• Study First Submitted QC: 2007-12-06
• Study First Posted: 2007-12-07
• Study Start: 2008-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2016-02-29
• Results First Submitted QC: 2016-05-18
• Results First Posted: 2016-06-28
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham (no treatment)	Sham	Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Treatment Surfactant (Infasurf) ONY, NY	Infasurf (ONY Inc.)	Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.

Primary Outcome Measures

Name	Time	Method
SP-B Content	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 Outcome Measures

Name	Time	Method
Alive Without BPD at 36 Weeks Post Menstrual Age	36 Weeks Post Menstrual Age	Alive without need for oxygen at 36 weeks post menstrual age.

Trial Locations

Locations (9)

Stony Brook University Medical Center; 🇺🇸 Stony Brook, New York, United States

Alta Bates Summit Medical Center; 🇺🇸 Berkeley, California, United States

Children's Hospital Oakland; 🇺🇸 Oakland, California, United States

Children's Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

Women and Children's Hospital of Buffalo; 🇺🇸 Buffalo, New York, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States