Melatonin Effects on the Left Ventricular Function in Neonates With Persistent Pulmonary Hypertension

Not Applicable

Completed

• Conditions: Melatonin; Left Ventricular Function; Neonates; Persistent Pulmonary Hypertension
• Interventions: Drug: Melatonin; Other: Placebo

• Registration Number: NCT07090720
• Lead Sponsor: Tanta University

Brief Summary

This study aimed to evaluate the effect of melatonin on the left ventricular function in neonates with persistent pulmonary hypertension

Detailed Description

Persistent pulmonary hypertension of the newborn (PPHN) is a potentially deadly disorder in which the circulation of the fetus is unable to adjust to the extrauterine environment. Persistently high pulmonary pressures may cause right-to-left shunting, hypoxia, and right ventricular failure.

Melatonin, a neurohormone produced by the pineal gland, offers an exceptional defense against reactive oxygen species (ROS). Infants are unable to synthesize melatonin during their first few weeks of life, which may exacerbate oxidative stress in hypoxic conditions. Additionally, Melatonin's antioxidative capabilities have been shown in neonatal pulmonary and respiratory disorders.

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-21
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-29
• Last Update Posted: 2025-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Neonates of ≥ 36 weeks of gestational age.
• Both sexes.
• Admitted with persistent pulmonary hypertension.

Exclusion Criteria

• Preterm infants < 36 weeks of gestation.
• Infants with congenital heart diseases.
• Infants with dysrhythmia.
• Chromosomal abnormalities.
• Severe pathological jaundice.
• Metabolic or endocrinal disorders.
• Major congenital malformations.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Melatonin	Neonates were given Melatonin.
Group II	Placebo	Neonates received placebo.

Primary Outcome Measures

Name	Time	Method
Left ventricle global longitudinal strain	Immediately after medication (Up to 1 hour)	Left ventricle global longitudinal strain (LV-GLS) was recorded.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt