Melatonin plus inhaled nitric oxide for pulmonary hypertension in full-term newborns

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 interventional study compares two groups of term neonates with pulmonary hypertension: one receiving inhaled nitric oxide plus melatonin and the other receiving inhaled nitric oxide alone. Melatonin is given via nasogastric tube at 3 mg/kg every 8 hours during iNO therapy. The trial monitors oxygenation and cerebral perfusion, with iNO dosing adjusted by clinical response, and rescue milrinone allowed if needed. Primary goals include safety and potential improvement in oxygenation and stability; responders may be weaned from iNO as clinically indicated. The study is conducted at Ain Shams University and aims to see if melatonin provides added benefit when used with iNO in this population.

Why it matters

Who can join: the full rules

Inclusion criteria :

* Term neonates with gestational age ≥ 37 weeks.
* Mean Pulmonary artery pressure greater than 25mmHg with clinical manifestations as tachypnea, tachycardia, hypoxemia and hypotension

Exclusion criteria :

* Congenital methemoglobinemia.
* Major congenital cardiac anomalies especially duct dependent systemic circulation.
* Bleeding tendency.
* Patients on other pulmonary vasodilators

Where it's running

• Ain Shams University
  Cairo, Abbassia, Egypt Recruiting

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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.