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

Roberta Ballard

Status and phase: Completed; Phase 3

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

Treatments: Drug: Sham; Drug: Infasurf (ONY Inc.)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00569530

IND79367 (Other Identifier)

H10842-31630-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 7 to 14 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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85 participants in 2 patient groups, including a placebo group

Treatment Surfactant (Infasurf) ONY, NY

Active Comparator group

Description:

Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.

Treatment:

Drug: Infasurf (ONY Inc.)

Sham (no treatment)

Placebo Comparator group

Description:

Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.

Treatment:

Drug: Sham