Clinical Trial: Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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 Summary: 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 20 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.
Sponsor: University of California, San Francisco

Current Primary Outcome: Survival without BPD at 36 weeks post menstrual age. [ Time Frame: 36 weeks post menstrual age +/- 1 week ]

Original Primary Outcome: Same as current

Current Secondary Outcome: a) discharge home or off respiratory support at 40 weeks post menstrual age b) measures of BPD severity c) pulmonary outcome after discharge d) pulmonary and neurodevelopmental outcomes through 2 years of age [ Time Frame: 22 months ]

Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: November 19, 2009
Date Started: January 2010
Date Completion: July 2015
Last Updated: September 20, 2013
Last Verified: September 2013