Phase 3 N=85 Randomized Quadruple-blind Treatment

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

Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction) · Bronchopulmonary Dysplasia

Bottom Line

View on ClinicalTrials.gov: NCT00569530 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2016

Primary outcome: Primary: SP-B Content — 19.9; 13.3 Total surfactant protein (% of PL)

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Infasurf (ONY Inc.) (Drug); Sham (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Roberta Ballard
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY SP-B Content	19.9; 13.3	—
SECONDARY Alive Without BPD at 36 Weeks Post Menstrual Age	16; 14	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00569530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.