CompletedPhase 3

Melatonin for Pulmonary Hypertension in Full Term Neonates

Egypt40 participantsStarted 2024-05-15

Plain-language summary

Published evidence has provided a possible role of melatonin and the treatment of pulmonary hypertension through its strong antioxidant properties and improving vascular function in animals. This study will test the hypothesis of the possible use of melatonin as an adjunct therapy to milrinone for neonatal pulmonary hypertension.

Who can participate

Age range28 Days

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * full term neonates ≥37 weeks diagnosed with pulmonary hypertension, with Pulmonary arterial pressure (PAP) \> 25 mm Hg measured by echocardiography, within 72 h of birth (Chetan et al., 2022). Exclusion Criteria: * Neonates with major congenital anomalies like congenital heart diseases * NPO or any contraindications to oral intake * Neonates with suspected inborn error of metabolism

What they're measuring

Pulmonary arterial pressure

Timeframe: After 72 hours of the start of the drug

FiO2

Timeframe: Hourly for 3 days

Trial details

NCT IDNCT06685679

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-15

View on ClinicalTrials.gov More Neonatal Diseases and Abnormalities trials