Inhaled nitric oxide tested in newborns with breathing failure and high lung blood pressure
Tests inhaled nitric oxide in newborns with low oxygen and pulmonary hypertension.
Plain-language title generated from the registry record
Registry title: Inhaled Nitric Oxide for the Treatment of Neonatal Hypoxic Respiratory Failure With Pulmonary Hypertension
Key facts
- Where
- Guangzhou, ChinaSee the site
Where in China
- Guangzhou Women and Children's medical centerGuangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Lee's Pharmaceutical Limited
- Trial code
- NCT07099144
- Record updated
- 1 August 2025
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: 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).
Exclusion: Neonates whose mother has been treated with anticoagulant therapies during pregnancy; ECMO is urgently needed, or neonate has received ECMO; Active seizures while receiving anticonvulsants; Life-threatening abnormality (cranial, cardiac, thoracic); Congenital heart defect (other than patent ductus arteriosus or small atrial septal defect); Significant bleeding diathesis such as grade IV intraventricular hemorrhage or periventricular leukomalacia, pulmonary hemorrhage, uncontrolled bleeding or hemodynamic failure; Receiving nitric oxide donor agents such as prilocaine, sodium nitroprusside, nitroglycerin, and sulfonamides; Neonates dependent on right-to-left shunting of blood; Echocardiography confirmed left-to-right shunt or left ventricular dysfunction; Patient is at risk of imminent death (death expected within 24 hours); Chromosomal abnormality; Congenital diaphragmatic hernia; Neonate has been resuscitated requiring chest compressions within 6 hours of study treatment start; Disseminated intravascular coagulopathy; Experienced prolong asphyxia with evidence of severe acidosis (pH<7.25); Other subjects determined by the investigator to be unsuitable for inclusion.