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NCT01022580 · ClinicalTrials.gov registry record · Phase 3
Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia
A Phase 3 study of Bronchopulmonary Dysplasia, sponsored by Roberta Ballard.
- Completed
- Registry status
- Phase 3
- Development phase
- 511
- Enrollment target
- 20
- Study locations
NCT01022580: Completed Phase 3 study of Bronchopulmonary Dysplasia, sponsored by Roberta Ballard.
NCT01022580 is a Phase 3 study of Bronchopulmonary Dysplasia that has completed, run by Roberta Ballard. The registered enrollment target is 511 participants, above the 219-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (133% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01022580, a Phase 3 study of Bronchopulmonary Dysplasia, has completed, sponsored by Roberta Ballard.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 511 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
BPD was diagnosed as need for respiratory support with either positive pressure and/or oxygen as evaluated by physiological oxygen/flow reduction.
Conditions Studied
Interventions
- DRUG Infasurf surfactant (ONY, Inc.)
- DRUG Sham (No Treatment)
Study Locations (20)
California
- Alta Bates Medical Center - Berkeley
- Oakland Children's Hospital - Oakland
- University of California, San Francisco - San Francisco
Florida
- Wolfson Children's Hospital and Shands HospitaL - Jacksonville
- Florida Hospital for Children - Orlando
- All Children's Hospital - St. Petersburg
Minnesota
- Childrens Hospital and Clinics of Minnesota- Minneapolis - Minneapolis
- University of Minnesota Medical School - Minneapolis
- Children's Hospital and Clinics of Minnesota - St Paul - Saint Paul
Illinois
- Northwestern Memorial Hospital - Chicago
- Children's Memorial Hospital - Chicago
New York
- Women's and Children's Hospital of Buffalo - Buffalo
- Stony Brook University Medical Center - Stony Brook
Texas
- UT Houston Health Science Center - Houston
- Texas Children's Hospital - Houston
Arkansas
- University of Arkansas - Arkansas Childrens Hospital - Little Rock
Missouri
- Children's Mercy Hospital - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 511 participants |
| Start Date | 2010-01 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
What the finished NCT01022580 record still lists
NCT01022580 is an interventional study that assigns participants to a tested intervention. The registered 511 participants enrollment target is mid-sized for trials with a published cap, above the 219-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (133% higher).
The record links to 1 condition, with Bronchopulmonary Dysplasia appearing as the primary indexed condition, and to 2 interventions - of which Infasurf surfactant (ONY, Inc.) is the first listed.
NCT01022580 names 20 study sites across 11 states, led by California, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT01022580 about?
NCT01022580 is a clinical study titled "Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia". 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.
What is the current status of trial NCT01022580?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 511 participants. The study started on 2010-01. Estimated completion is 2016-01.
What conditions does trial NCT01022580 study?
This clinical trial studies the following conditions: Bronchopulmonary Dysplasia.
What interventions are being tested in trial NCT01022580?
The interventions under investigation include: Infasurf surfactant (ONY, Inc.) (DRUG), Sham (No Treatment) (DRUG).
Who is sponsoring clinical trial NCT01022580?
This trial is sponsored by Roberta Ballard, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01022580 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bronchopulmonary Dysplasia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01022580's enrollment target sits among peer trials
511 5th of 29 higher than 25 of 29 other Bronchopulmonary Dysplasia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bronchopulmonary Dysplasia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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