Melatonin Effects on the Left Ventricular Function in Neo... | NCT07090720

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

NCT07090720

Sponsor

Tanta University

Status

Completed

Last Update Posted

Jul 29, 2025Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Melatonin
Left Ventricular Function
Neonates
Persistent Pulmonary Hypertension

Interventions

Melatonin
Placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Jan 1, 2025Actual

Completion Date

Jan 1, 2025Actual

First Submitted Date

Jul 21, 2025

First Submission Date that Met QC Criteria

Jul 21, 2025

First Posted Date

Jul 29, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2025

Last Update Posted Date

Jul 29, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Asmaa Mahmoud Abdel Hamid Elmesiry, Lecturer of Pediatrics, Faculty of Medicine, Tanta University, Tanta, Egypt., Tanta UniversityPrincipal Investigator

Lead Sponsor

Tanta UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group I	Experimental	Neonates were given Melatonin.	Drug: Melatonin
Group II	Placebo Comparator	Neonates received placebo.	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Melatonin	Drug	Neonates were given Melatonin.	Group I
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

36 Weeks

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta University		Tanta	El-Gharbia	31527	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41954764	Derived	Nofal SM, El-Mashad AM, Elmesiry AM, Abouelenain AM, Awny MM. Melatonin effects on the left ventricular function in neonates with persistent pulmonary hypertension. Eur J Pediatr. 2026 Apr 9;185(5):247. doi: 10.1007/s00431-026-06864-z.

ID	Term
D014363	Tryptamines
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring