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NCT00931632 · ClinicalTrials.gov registry record · Phase 3
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
A Phase 3 study of Bronchopulmonary Dysplasia, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 3
- Development phase
- 451
- Enrollment target
- 20
- Study locations
NCT00931632 is a Phase 3 study of Bronchopulmonary Dysplasia that has completed, run by Mallinckrodt. The registered enrollment target is 451 participants, above the 221-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (104% higher). The trial reports 20 study locations across 11 states.
The verdict
NCT00931632, a Phase 3 study of Bronchopulmonary Dysplasia, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 451 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5 to 14 after birth may benefit from treatment with iNO.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Inhaled Nitric Oxide
Study Locations (20)
California
- Loma Linda University School of Medicine - Loma Linda
- Children's Hospital of Orange County - Orange
- Stanford University School of Medicine - Palo Alto
- Rady Children's Hospital of San Diego - San Diego
- Sharp Mary Birch Hospital for Women and Newborns - San Diego
New Jersey
- Saint Barnabas Medical Center - Livingston
- Jersey Shore University Medical Center - Neptune City
- Robert Wood Johnson University Hospital - New Brunswick
Arizona
- Phoenix Children's Hospital - Phoenix
- St. Joseph's Hospital and Medical Center - Phoenix
Florida
- Winnie Palmer Hospital for Women and Babies - Orlando
- University of So Florida College of Medicine - Tampa
New York
- Winthrop University Hospital - Mineola
- Montefiore Medical Center - The Bronx
Connecticut
- Connecticut Children's Medical Center - Hartford
Georgia
- Medical College of Georgia - Augusta
Illinois
- Advocate Lutheran General Children's Hospital - Park Ridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 451 participants |
| Start Date | 2009-11 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00931632
The ClinicalTrials.gov registry entry for NCT00931632 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 451 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 221-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (104% higher). The listed sponsor is Mallinckrodt, which has 69 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 Placebo is the first listed.
NCT00931632 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, New Jersey, Arizona.
Frequently Asked Questions
What is clinical trial NCT00931632 about?
NCT00931632 is a clinical study titled "Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants". This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5 to 14 after birth may benefit from treatment with iNO.
What is the current status of trial NCT00931632?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 451 participants. The study started on 2009-11. Estimated completion is 2014-05.
What conditions does trial NCT00931632 study?
This clinical trial studies the following conditions: Bronchopulmonary Dysplasia.
What interventions are being tested in trial NCT00931632?
The interventions under investigation include: Placebo (DRUG), Inhaled Nitric Oxide (DRUG).
Who is sponsoring clinical trial NCT00931632?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00931632 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. 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.