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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07090720
Enrollment
80
Registered
2025-07-29
Start date
2023-01-01
Completion date
2025-01-01
Last updated
2025-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left Ventricular Function, Melatonin, Neonates, Persistent Pulmonary Hypertension

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.

Interventions

DRUGMelatonin

Neonates were given Melatonin.

OTHERPlacebo

Neonates received placebo.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
36 Weeks to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Left ventricle global longitudinal strainImmediately after medication (Up to 1 hour)Left ventricle global longitudinal strain (LV-GLS) was recorded.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026