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NCT03132428 · ClinicalTrials.gov registry record
Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension
A clinical trial, sponsored by Mallinckrodt.
- Terminated
- Registry status
- 140
- Enrollment target
NCT03132428: Clinical Trial study, sponsored by Mallinckrodt.
NCT03132428 is a clinical trial that was terminated before completion, run by Mallinckrodt. The registered enrollment target is 140 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03132428 was terminated before completion, sponsored by Mallinckrodt.
- TERMINATED
- Registry status
- 140 participants
- Enrollment target
Study Summary
Pulmonary hypertension is high blood pressure in the arteries to the lungs. It is a serious condition. It causes the blood vessels that carry blood from the heart to the lungs to become hard and narrow. When this happens, the heart has to work harder to pump the blood through. Some babies are born with pulmonary hypertension (PH). Doctors might use INOmax (a gas the baby breathes) to help newborn babies (neonates) with PH. This study will use information from the records of registered babies to see how effective and safe INOmax is for treating premature and other newborn babies for up to 11 days after they are born.
Primary Outcome
Significant response is defined as at least a 25% improvement from baseline in oxygenation index or surrogate oxygenation index (OI/SOI) during INOMAX treatment
Interventions
- DRUG INOmax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2017-07-27 |
| Est. Completion | 2020-02-11 |
Why NCT03132428 stopped before completion
NCT03132428 is an observational study that tracks outcomes without assigning an intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which INOmax is the first listed.
NCT03132428 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03132428 about?
NCT03132428 is a clinical study titled "Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension". Pulmonary hypertension is high blood pressure in the arteries to the lungs. It is a serious condition. It causes the blood vessels that carry blood from the heart to the lungs to become hard and narrow. When this happens, the heart has to work harder to pump the blood through. Some babies are born ...
What is the current status of trial NCT03132428?
This trial is currently terminated. The enrollment target is 140 participants. The study started on 2017-07-27. Estimated completion is 2020-02-11.
What interventions are being tested in trial NCT03132428?
The interventions under investigation include: INOmax (DRUG).
Who is sponsoring clinical trial NCT03132428?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
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