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Effect of Melatonin on Pulmonary Hypertension in Full Term Neonates

The aim of the study 1. To evaluate safety and efficacy of melatonin as an adjuvant therapy to inhaled nitric oxide generated by NO generator in the treatment of pulmonary hypertension in full term neonates. 2. To assess the effect of inhaled nitric oxide and melatonin on cerebral perfusion.

ClinicalTrials.gov IDNCT07850934

PhaseNA

Enrollment52

SponsorAin Shams University

AgeNot reported

SexALL

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Conditions studied

Congenital Peumonia, Persistent Pulmonary Hypertension of Newborn, Congenital Diaphragmatic Hernia

About this study

Interventions

Drug: Melatonin — Melatonin will be given by nasogastric tube at a dose (3 mg/kg) divided every 8 hours till the end of iNO therapy
Device: nitric oxide generator — iNO will be initiated at 20 ppm. The expected clinical response will be improved oxygenation and cardio-respiratory stability in the first 30 minutes after initiation of iNO therapy.If there is no clinical response, the iNO dose will be increased to up to 40 ppm. If after 30 minutes there is no clinical response, iNO will be discontinued

Primary outcomes

melatonin as an adjuvant therapy to iNO (72 hours)

Eligibility information

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

Study locations

Ain Shams University, Cairo, Abbassia 00202 Egypt

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-13.