Actively Recruiting
Inhaled Nitric Oxide for the Treatment of Neonatal Hypoxic Respiratory Failure With Pulmonary Hypertension
Led by Lee's Pharmaceutical Limited · Updated on 2025-08-01
120
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Inhaled Nitric Oxide for the Treatment of Neonatal Hypoxic Respiratory Failure With Pulmonary Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonates at least 34 weeks gestational age
- Hypoxic respiratory failure requiring more than 24 hours of ventilatory support
- Clinical or echocardiographic evidence of pulmonary hypertension (systolic pulmonary arterial pressure > 35 mm Hg or > 2/3 systemic blood pressure, or right-to-left shunt at atrium or arterial ductus)
- Age less than 7 days at treatment start
- Neonatal guardian agrees to participate and signs informed consent
You will not qualify if you...
- Neonates dependent on right-to-left shunting of blood
- Neonates whose mother received anticoagulant therapy during pregnancy
- Echocardiography showing left-to-right shunt or left ventricular dysfunction
- Need for or prior use of ECMO
- Patient expected to die within 24 hours
- Life-threatening abnormalities of the brain, heart, or chest
- Chromosomal abnormalities
- Congenital diaphragmatic hernia
- Congenital heart defects other than patent ductus arteriosus or small atrial septal defect
- Neonate resuscitated with chest compressions within 6 hours before treatment
- Significant bleeding disorders such as severe brain hemorrhage, pulmonary hemorrhage, uncontrolled bleeding, or hemodynamic failure
- Disseminated intravascular coagulopathy
- Active seizures while on anticonvulsants
- Severe asphyxia with acidosis (pH < 7.25)
- Receiving nitric oxide donor agents like prilocaine, sodium nitroprusside, nitroglycerin, or sulfonamides
- Other conditions deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Guangzhou Women and Children'S Medical Center
Guangzhou, Guangdong, China, 510623
Actively Recruiting
Research Team
W
Wen hao Zhou
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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