RecruitingNCT07099144

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

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.


Sponsor

Lee's Pharmaceutical Limited

Enrollment

120 participants

Start Date

Dec 12, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Max Age: 7 Days

Plain Language Summary

Simplified for easier understanding

This study is testing inhaled nitric oxide — a gas that helps open up blood vessels in the lungs — as a treatment for newborns who are having trouble breathing due to a condition called pulmonary hypertension (high blood pressure in the lungs) combined with low oxygen levels (hypoxic respiratory failure). **You may be eligible if...** - Your baby was born at 34 weeks of pregnancy or later - Your baby is less than 7 days old - Your baby is on a breathing machine due to low oxygen levels - Your baby has evidence of high lung blood pressure on an ultrasound of the heart **You may NOT be eligible if...** - Your baby's survival depends on blood flowing in the wrong direction through a heart defect - Your baby has a congenital heart defect (other than a small hole in the heart) - Your baby has a life-threatening birth defect (brain, heart, or chest) - Your baby has a chromosomal condition - Your baby needs emergency life support (ECMO) or is expected to die within 24 hours - Your baby has severe brain bleeding or blood clotting problems - Your baby is having active seizures on anti-seizure medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInhaled 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

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NCT07099144


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