Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia: A Study in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide
Overview
- Phase
- Phase 3
- Intervention
- Infasurf surfactant (ONY, Inc.)
- Conditions
- Bronchopulmonary Dysplasia
- Sponsor
- Roberta Ballard
- Enrollment
- 511
- Locations
- 21
- Primary Endpoint
- Survival Without BPD at 36 Weeks Post Menstrual Age.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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 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.
Investigators
Roberta Ballard
Professor of Pediatrics
University of California, San Francisco
Eligibility Criteria
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
Arms & Interventions
Infasurf surfactant (ONY, Inc.)
Infants already receiving inhaled nitric oxide will receive scheduled doses of late surfactant (Infasurf) on study days 0, 2, 4, 6 and 8.
Intervention: Infasurf surfactant (ONY, Inc.)
Sham (No Treatment)
Infants already receiving inhaled nitric oxide will receive "Sham (no treatment)" doses on study days 0,2,4,6, and 8.
Intervention: Sham (No Treatment)
Outcomes
Primary Outcomes
Survival Without BPD at 36 Weeks Post Menstrual Age.
Time Frame: 36 weeks post menstrual age +/- 1 week
BPD was diagnosed as need for respiratory support with either positive pressure and/or oxygen as evaluated by physiological oxygen/flow reduction.
Secondary Outcomes
- Respiratory Outcomes of TOLSURF Infants at 1 Year Corrected Age(1 year)
- Pulmonary Outcomes Through 2 Years of Age(2 years)
- Percentage of Participants With Neurodevelopmental Impairment (NDI) at 2 Years.(2 years)
- Survival Without BPD at 40 Weeks(40 weeks PMA +/- 1 week)