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Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
NCT00931632 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 451 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mallinckrodt, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00931632 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, New Jersey, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00931632?
The interventions under investigation include: Placebo (DRUG), Inhaled Nitric Oxide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00931632?
This trial is sponsored by Mallinckrodt, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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