Inhaled nitric oxide for newborns with hypoxic respiratory failure and pulmonary hypertension

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 study will try inhaled nitric oxide with ventilator support to help improve oxygen levels in newborns (≥34 weeks) who have hypoxic respiratory failure and pulmonary hypertension.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: N/A to 7 Days
• Sex: All
• Sponsor: Lee's Pharmaceutical Limited (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07099144 on ClinicalTrials.gov

What this trial studies

This is a prospective, open-label, single-arm Phase IV safety study administering INOmax (inhaled nitric oxide) to ventilated newborns ≥34 weeks gestation with hypoxic respiratory failure and clinical or echocardiographic evidence of pulmonary hypertension. Treatment starts at 20 ppm controlled by the INOmax delivery system for 4 hours, then can be weaned to 5 ppm within 4–24 hours if arterial oxygenation is adequate, and continued until FiO2 is below 0.60. Dosing and use occur in NICU settings with mechanical ventilation and resuscitation available and are supervised by an experienced neonatal physician. Maintenance treatment is usually under 96 hours, and continued use beyond that requires reassessment by the investigator.

Who should consider this trial

Good fit: Ideal candidates are newborns ≥34 weeks gestation and under 7 days old who require more than 24 hours of ventilatory support for hypoxic respiratory failure and have clinical or echocardiographic signs of pulmonary hypertension.

Not a fit: Newborns dependent on right-to-left shunting, with confirmed left ventricular dysfunction or left-to-right shunts, already on or needing urgent ECMO, at high risk of imminent death, or otherwise meeting exclusion criteria are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could improve oxygenation quickly and reduce the need for extracorporeal support in affected newborns.

How similar studies have performed: Inhaled nitric oxide is an established rescue therapy for neonatal pulmonary hypertension with multiple prior studies showing rapid improvement in oxygenation and reduced need for ECMO in many cases.

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.

Where this trial is running

Guangzhou, Guangdong

• Guangzhou Women and Children'S Medical Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Wen hao Zhou

Conditions Pulmonary Hypertension; Hypoxic Respiratory Failure