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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03132428
Other study ID # MNK19050056
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date July 27, 2017
Est. completion date February 11, 2020

Study information

Verified date June 2020
Source Mallinckrodt
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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Study Design


Related Conditions & MeSH terms


Intervention

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

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Sponsors (1)

Lead Sponsor Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of neonates with significant response to INOmax treatment within each age group Significant response is defined as at least a 25% improvement from baseline in oxygenation index or surrogate oxygenation index (OI/SOI) during INOMAX treatment within 108 hours
Secondary Number of neonates with significant response to Inomax treatment within each age group and severity group The severity of pulmonary hypertension (PH) is classified for each participant Categories: Mild, Moderate, Severe within 108 hours
Secondary Time to reach significant response to Inomax treatment within each age group and severity group The median time to INOmax complete response (25% improvement) for neonates with each baseline PH severity classification Categories: Mild, Moderate, Severe within 108 hours
Secondary Number of neonates with partial response to INOmax treatment within each age group and severity group Partial response is defined as less than a 25% improvement in OI/SOI during INOmax treatment within 108 hours
See also
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Enrolling by invitation NCT04031508 - Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH Phase 2
Completed NCT05050045 - Echocardiographic Screening of Healthy Neonates for Measuring Pulmonary Artery Pressure