Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide (TOLSURFPilot)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00569530|
Recruitment Status : Completed
First Posted : December 7, 2007
Results First Posted : June 28, 2016
Last Update Posted : May 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction) Bronchopulmonary Dysplasia||Drug: Infasurf (ONY Inc.) Drug: Sham||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Active Comparator: Treatment Surfactant (Infasurf) ONY, NY
Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Drug: Infasurf (ONY Inc.)
Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14, if remains intubated.
Other Name: Infasurf
Placebo Comparator: Sham (no treatment)
Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Sham instillation (no treatment) will be given to study infants on days 0, 3, 7, 10, and 14, if remains intubated.
Other Name: Air
- SP-B Content [ Time Frame: One day after dose ]SP-B Content is the surfactant protein B found in terms of percentage of phospholipid measured one day after surfactant or sham dose.
- Alive Without BPD at 36 Weeks Post Menstrual Age [ Time Frame: 36 Weeks Post Menstrual Age ]Alive without need for oxygen at 36 weeks post menstrual age.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569530
|United States, California|
|Alta Bates Summit Medical Center|
|Berkeley, California, United States, 94705|
|Children's Hospital Oakland|
|Oakland, California, United States, 94609|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Children's Memorial Hospital|
|Chicago, Illinois, United States, 60614|
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|United States, New York|
|Women and Children's Hospital of Buffalo|
|Buffalo, New York, United States, 14222|
|Stony Brook University Medical Center|
|Stony Brook, New York, United States, 11794|
|United States, Texas|
|Texas Children's Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Roberta A Ballard, MD||University of California, San Francisco|