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NCT01748045 · ClinicalTrials.gov registry record · Phase 2
Study of Inhaled Nitric Oxide (iNO) and Respiratory Outcomes in Late Preterm Infants
A Phase 2 study, sponsored by Tufts Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT01748045 is a Phase 2 study that was terminated before completion, run by Tufts Medical Center. The registered enrollment target is 3 participants.
The verdict
NCT01748045, a Phase 2 study, was terminated before completion, sponsored by Tufts Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
The aim of this study is to determine if inhaled nitric oxide will improve short and long term respiratory outcomes in preterm infants. Infants born at a gestational age of 30-36 weeks and who require breathing support with high flow nasal cannula, nasal continuous positive airway pressure, or nasal intermittent positive pressure will be randomized to receive either inhaled nitric oxide or placebo. The dose will then be decreased per protocol until all respiratory support has been discontinued. Infants will be followed to evaluate safety and efficacy of non-invasive iNO delivery, up to 12 months corrected gestational age.
Interventions
- DRUG inhaled nitric oxide
- DRUG Placebo Comparator - nitrogen gas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2013-03 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01748045
The ClinicalTrials.gov registry entry for NCT01748045 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tufts Medical Center, which has 169 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which inhaled nitric oxide is the first listed.
NCT01748045 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01748045 about?
NCT01748045 is a clinical study titled "Study of Inhaled Nitric Oxide (iNO) and Respiratory Outcomes in Late Preterm Infants". The aim of this study is to determine if inhaled nitric oxide will improve short and long term respiratory outcomes in preterm infants. Infants born at a gestational age of 30-36 weeks and who require breathing support with high flow nasal cannula, nasal continuous positive airway pressure, or nasal...
What is the current status of trial NCT01748045?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2013-03. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01748045?
The interventions under investigation include: inhaled nitric oxide (DRUG), Placebo Comparator - nitrogen gas (DRUG).
Who is sponsoring clinical trial NCT01748045?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
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