NCT07099144 Inhaled Nitric Oxide for the Treatment of Neonatal Hypoxic Respiratory Failure With Pulmonary Hypertension
| NCT ID | NCT07099144 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lee's Pharmaceutical Limited |
| Condition | Pulmonary Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-12-12 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2024-12-12 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Neonates ≥ 34 weeks gestation age. 2. Hypoxic respiratory failure requiring more than 24 hours of ventilatory support. 3. Clinical or echocardiographic evidence of pulmonary hypertension (systolic pulmonary arterial pressure \[sPAP\] \> 35 mm Hg or \> 2/3 systemic blood pressure \[SBP\] or there is a right-to-left shunt at the atrium or arterial ductus). 4. Age less than 7 days at the time of treatment initiation with study drug. 5. The neonatal guardian agrees to participate in the study and signs an informed consent form (ICF). Exclusion Criteria: 1. Neonates dependent on right-to-left shunting of blood. 2. Neonates whose mother has been treated with anticoagulant therapies during pregnancy. 3. Echocardiography confirmed left-to-right shunt or left ventricular dysfunction. 4. ECMO is urgently needed, or neonate has received ECMO. 5. Patient is at risk of imminent death (death expected within 24 hours). 6. Life-threatening abnormality (cranial, cardiac, thoracic). 7. Chromosomal abnormality. 8. Congenital diaphragmatic hernia 9. Congenital heart defect (other than patent ductus arteriosus or small atrial septal defect). 10. Neonate has been resuscitated requiring chest compressions within 6 hours of study treatment start. 11. Significant bleeding diathesis such as grade IV intraventricular hemorrhage or periventricular leukomalacia, pulmonary hemorrhage, uncontrolled bleeding or hemodynamic failure. 12. Disseminated intravascular coagulopathy. 13. Active seizures while receiving anticonvulsants. 14. Experienced prolong asphyxia with evidence of severe acidosis (pH\<7.25) 15. Receiving nitric oxide donor agents such as prilocaine, sodium nitroprusside, nitroglycerin, and sulfonamides. 16. Other subjects determined by the investigator to be unsuitable for inclusion.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07099144 clinical trial?
This trial is open to participants of all sexes, up to 7 Days, studying Pulmonary Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07099144 currently recruiting?
Yes, NCT07099144 is actively recruiting participants. Contact the research team at zwhchfu@126.com for enrollment information.
Where is the NCT07099144 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07099144 clinical trial?
NCT07099144 is sponsored by Lee's Pharmaceutical Limited. The trial plans to enroll 120 participants.