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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01022580
The ClinicalTrials.gov registry entry for NCT01022580 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 511 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 219-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (133% higher). The listed sponsor is Roberta Ballard, which has 2 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.