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Completed

NCT Number: NCT07090720

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

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

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Key information

Conditions

Melatonin Left Ventricular Function Neonates Persistent Pulmonary Hypertension

Age range

36 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Melatonin

Drug

Neonates were given Melatonin.

Placebo

Other

Neonates received placebo.

Primary outcomes

  1. Left ventricle global longitudinal strain

    Time frame: Immediately after medication (Up to 1 hour)

    Left ventricle global longitudinal strain (LV-GLS) was recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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