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

NCT ID: NCT07090720

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-01-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Melatonin Left Ventricular Function Neonates Persistent Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group I

Neonates were given Melatonin.

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

Neonates were given Melatonin.

Group II

Neonates received placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Neonates received placebo.

Interventions

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Melatonin

Neonates were given Melatonin.

Intervention Type DRUG

Placebo

Neonates received placebo.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Mahmoud Abdel Hamid Elmesiry

Lecturer of Pediatrics, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, El-Gharbia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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36173//12/22

Identifier Type: -

Identifier Source: org_study_id

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