NCT03132428

Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension

Multicenter, Prospectively Defined Observational Registry With Retrospective Data Collection, Evaluating Premature and Term-Near-Term Neonates With Pulmonary Hypertension Receiving Inhaled Nitric Oxide Via Invasive or Noninvasive Ventilation

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 140 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 27 Weeks – 40 Weeks
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	INOmax	Nitric oxide gas for inhalation provided via mechanical ventilation or non invasive ventilation

Timeline

• Start date: 2017-07-27
• Primary completion: 2020-02-11
• Completion: 2020-02-11
• First posted: 2017-04-27
• Last updated: 2020-06-18

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated drug study