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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Wen hao Zhou
• Email: zwhchfu@126.com
• Phone: +86-18017591123

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.