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Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension

NCT03132428 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2020-06-18

No results posted yet for this 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.

Conditions

  • Pulmonary Hypertension of Newborn

Interventions

DRUG

INOmax

Nitric oxide gas for inhalation provided via mechanical ventilation or non invasive ventilation

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Clinical Team Leader · Mallinckrodt

Eligibility

Min Age
27 Weeks
Max Age
40 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-27
Primary Completion
2020-02-11
Completion
2020-02-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03132428 on ClinicalTrials.gov