Inhaled Nitric Oxide for the Treatment of Neonatal Hypoxic Respiratory Failure With Pulmonary Hypertension
Recruiting now
Conditions studied: Pulmonary Hypertension, Hypoxic Respiratory Failure
In brief
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.
Key facts
- Study ID
- NCT07099144
- Run by
- Lee's Pharmaceutical Limited
- People needed
- 120
- Starts
- 2024-12-12
- Expected to finish
- 2026-12-30
- Last updated by the study team
- 2025-08-01
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Neonates ≥ 34 weeks gestation age.
- Hypoxic respiratory failure requiring more than 24 hours of ventilatory support.
- 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).
- Age less than 7 days at the time of treatment initiation with study drug.
- The neonatal guardian agrees to participate in the study and signs an informed consent form (ICF).
You may not qualify if…
- Neonates dependent on right-to-left shunting of blood.
- Neonates whose mother has been treated with anticoagulant therapies during pregnancy.
- Echocardiography confirmed left-to-right shunt or left ventricular dysfunction.
- ECMO is urgently needed, or neonate has received ECMO.
- Patient is at risk of imminent death (death expected within 24 hours).
- Life-threatening abnormality (cranial, cardiac, thoracic).
- Chromosomal abnormality.
- Congenital diaphragmatic hernia
- Congenital heart defect (other than patent ductus arteriosus or small atrial septal defect).
- Neonate has been resuscitated requiring chest compressions within 6 hours of study treatment start.
- Significant bleeding diathesis such as grade IV intraventricular hemorrhage or periventricular leukomalacia, pulmonary hemorrhage, uncontrolled bleeding or hemodynamic failure.
- Disseminated intravascular coagulopathy.
- Active seizures while receiving anticonvulsants.
- Experienced prolong asphyxia with evidence of severe acidosis (pH<7.25)
- Receiving nitric oxide donor agents such as prilocaine, sodium nitroprusside, nitroglycerin, and sulfonamides.
- Other subjects determined by the investigator to be unsuitable for inclusion.
Where it is running
- Guangzhou Women and Children'S Medical Center — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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