NCT01022580

Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia

Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia: A Study in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 511 (actual)
• Sponsor: Roberta Ballard · Academic / Other
• Sex: All
• Age: 7 Days – 14 Days
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if late doses of Infasurf surfactant given when patients are receiving inhaled nitric oxide will interact to improve surfactant function and increase survival without BPD in treated infants.

Detailed description

This is a multi-center, blinded, randomized controlled clinical trial to evaluate the effects of booster doses of exogenous surfactant (Infasurf®, calfactant) in addition to inhaled nitric oxide (iNO) on the outcome of survival without bronchopulmonary dysplasia (BPD, or chronic lung disease of prematurity, characterized by chronic lung dysfunction) at 36 weeks' post-menstrual age (PMA) in extremely low gestational age (ELGAN) infants that are at high risk of the development of BPD. This multi-center trial, with a planned enrollment of 524 infants, will also enable us to evaluate for any adverse effects of late surfactant treatment on short- and long-term outcomes, as we will be collecting data on effects of dosing of late surfactant, co-morbidities of prematurity and neurodevelopmental and pulmonary outcome at 1 year and 24 months corrected age. In addition, we will collect biological specimens for evaluation of the effects of late surfactant replacement therapy (administered as described in this trial) on surfactant function and inflammatory markers.

Conditions

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
DRUG	Infasurf surfactant (ONY, Inc.)	Late doses of Infasurf 3ml/kg will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated.
DRUG	Sham (No Treatment)	Late doses of Sham (No treatment) will be given to infants on study days 0, 2, 4, 6 and 8 as long as infant remains intubated.

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-12-01
• Completion: 2016-01-01
• First posted: 2009-12-01
• Last updated: 2021-05-13
• Results posted: 2021-05-13

Locations

21 sites across 1 country: United States