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RECRUITING
NCT07850934
NA

Effect of Melatonin on Pulmonary Hypertension in Full Term Neonates

Sponsor: Ain Shams University

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2025-07-01

Completion Date

2026-12-01

Last Updated

2026-09-30

Healthy Volunteers

No

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

Locations (1)

Ain Shams University

Cairo, Abbassia, Egypt