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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 is a Phase 1 study that was terminated before completion, run by AdventHealth. The registered enrollment target is 32 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03576885
The ClinicalTrials.gov registry entry for NCT03576885 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AdventHealth, which has 95 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03576885 reports 0 study locations.
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.
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