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RECRUITING
NCT07099144

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

Sponsor: Lee's Pharmaceutical Limited

View on ClinicalTrials.gov

Summary

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.

Official title: A Prospective, Open, Single-arm, Multi-center Phase IV Clinical Study of Inhaled Nitric Oxide Combined With Ventilatory Support for the Treatment of Neonatal (Gestational Age ≥34 Weeks) Hypoxic Respiratory Failure With Pulmonary Hypertension.

Key Details

Gender

All

Age Range

Any - 7 Days

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2024-12-12

Completion Date

2026-12-30

Last Updated

2025-08-01

Healthy Volunteers

No

Interventions

DRUG

Inhaled nitric oxide (NO)

The starting dose of INOmax is 20 ppm, which is controlled by the INOmax DSIR Plus delivery system in the respiratory circuit during mechanical ventilation. The dose will be maintained at 20 ppm for 4 hours after the start of administration, then the dose can be weaned to 5 ppm provided that the arterial oxygenation is adequate, as determined by the investigator within 4-24 hours of therapy, and the therapy should be maintained at 5 ppm until the fraction of inspired oxygen (FiO2) \< 0.60. The treatment will be maintained until the potential hypoxia is resolved, or the investigator determines that the neonate no longer needs to use this drug. The maintenance treatment time is usually less than 4 days (96 hours). If the oxygenation level has not improved significantly after 4 days of maintenance treatment, the suitability of the treatment plan should be reassessed.

Locations (1)

Guangzhou Women and Children'S Medical Center

Guangzhou, Guangdong, China