Inhaled Nitric Oxide for the Treatment of Neonatal Hypoxic Respiratory Failure With Pulmonary Hypertension

This is a prospective, open-label, single-arm, multicenter Phase IV clinical study to evaluate the safety of INOmax for the treatment of hypoxic respiratory failure with pulmonary hypertension in newborns (≥ 34 weeks gestational age). To evaluate the safety of INOmax combined with ventilatory support in the treatment of neonatal (≥ 34 weeks gestational age) hypoxic respiratory failure with pulmonary hypertension.

NCT Number	NCT07099144
Lead Sponsor	Lee's Pharmaceutical Limited
Conditions	Pulmonary Hypertension, Hypoxic Respiratory Failure
Enrollment	120 participants
Start Date	2024-12-12
Primary Completion	2025-12-31 (estimated)
Study Completion	2026-12-30 (estimated)
Updated on ClinicalTrials.gov	2025-08-01