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

NCT07099144 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2025-08-01

No results posted yet for this study

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.

Conditions

  • Pulmonary Hypertension
  • Hypoxic 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.

Sponsors & Collaborators

  • Lee's Pharmaceutical Limited

    lead INDUSTRY

Eligibility

Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-12
Primary Completion
2025-12-31
Completion
2026-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07099144 on ClinicalTrials.gov