Overview

This trial is active, not recruiting.

Condition bronchopulmonary dysplasia
Treatment infasurf surfactant (ony, inc.)
Phase phase 3
Sponsor University of California, San Francisco
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date January 2010
End date December 2013
Trial size 524 participants
Trial identifier NCT01022580, H10842-33541-01A, U01HL094338

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Infants already receiving inhaled nitric oxide will receive scheduled doses of late surfactant (Infasurf) on study days 0, 2, 4, 6 and 8.
infasurf surfactant (ony, inc.)
Late doses of Infasurf 3ml/kg will be given to infants on study days 0, 2, 4, 6 and 8.
(Sham Comparator)
Infants already receiving inhaled nitric oxide will not receive additional doses of late surfactant (Infasurf).
infasurf surfactant (ony, inc.)
Late doses of Infasurf 3ml/kg will be given to infants on study days 0, 2, 4, 6 and 8.

Primary Outcomes

Measure
Survival without BPD at 36 weeks post menstrual age.
time frame: 36 weeks post menstrual age +/- 1 week

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants up to 14 days old.

Inclusion Criteria: - <=28 0/7 weeks gestational age - Day of life 7-14 - Intubated and mechanically ventilated - Plan to treat with inhaled nitric oxide Exclusion Criteria: - Serious congenital malformations or chromosomal abnormalities - Life expectancy <7 days from enrollment - Clinically unstable - Less tha 48 hours since last dose surfactant - Ability to obtain 36 week primary outcome information is unlikely

Additional Information

Official title Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia: A Study in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide
Principal investigator Roberta A Ballard, MD
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by University of California, San Francisco.