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

RecruitingOBSERVATIONAL
Enrollment

120

Participants

Timeline

Start Date

December 12, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 30, 2026

Conditions
Pulmonary HypertensionHypoxic Respiratory Failure
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."

Trial Locations (1)

510623

RECRUITING

Guangzhou Women and Children'S Medical Center, Guangzhou

Sponsors
All Listed Sponsors
lead

Lee's Pharmaceutical Limited

INDUSTRY