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NCT03576885 · ClinicalTrials.gov registry record · Phase 1
Inhaled Nitric Oxide for Pulmonary Hypertension and Bronchopulmonary Dysplasia
A Phase 1 study, sponsored by AdventHealth.
- Terminated
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT03576885: Clinical Trial Phase 1 study, sponsored by AdventHealth.
NCT03576885 is a Phase 1 study that was terminated before completion, run by AdventHealth. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03576885, a Phase 1 study, was terminated before completion, sponsored by AdventHealth.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
Inhaled nitric oxide (iNO) is an effective treatment for pulmonary hypertension (PH) in term and near-term infants. Preterm infants are at risk for early PH that is associated with high risk for bronchopulmonary dysplasia or death. In multiple clinical trials, iNO treatment was not effective for BPD prevention. However, infants were not screened for PH and iNO treatment was not targeted for PH. iNO treatment for PH in preterm infants is controversial due to lack of evidence. The study team hypothesizes that early diagnosis of PH (72-96 hours of life) and iNO treatment will decrease the incidence of death and bronchopulmonary dysplasia and improve oxygenation in extremely preterm infants. 1. To determine if iNO treatment of extremely preterm infants with early pulmonary hypertension as established with echocardiographic evidence at 72-96 hours of age will decrease incidence of death or BPD. 2. To determine if iNO treatment of extremely preterm infants with early PH will decrease the pulmonary artery pressure and improve oxygenation within 72 hours of intervention.
Primary Outcome
Incidence of death
Interventions
- DRUG Placebo
- DRUG inhaled nitric oxide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2019-07-15 |
| Est. Completion | 2023-10-09 |
| Phase | Phase 1 |
Why NCT03576885 stopped before completion
NCT03576885 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03576885 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03576885 about?
NCT03576885 is a clinical study titled "Inhaled Nitric Oxide for Pulmonary Hypertension and Bronchopulmonary Dysplasia". Inhaled nitric oxide (iNO) is an effective treatment for pulmonary hypertension (PH) in term and near-term infants. Preterm infants are at risk for early PH that is associated with high risk for bronchopulmonary dysplasia or death. In multiple clinical trials, iNO treatment was not effective for BPD...
What is the current status of trial NCT03576885?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2019-07-15. Estimated completion is 2023-10-09.
What interventions are being tested in trial NCT03576885?
The interventions under investigation include: Placebo (DRUG), inhaled nitric oxide (DRUG).
Who is sponsoring clinical trial NCT03576885?
This trial is sponsored by AdventHealth, which has 95 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03576885's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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