NCT07090720

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

July 21, 2025

Last Update Submit

July 21, 2025

Conditions

MelatoninLeft Ventricular FunctionNeonatesPersistent Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Left ventricle global longitudinal strain

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

    Immediately after medication (Up to 1 hour)

Study Arms (2)

Group I

EXPERIMENTAL

Neonates were given Melatonin.

Drug: Melatonin

Group II

PLACEBO COMPARATOR

Neonates received placebo.

Other: Placebo

Interventions

MelatoninDRUG

Neonates were given Melatonin.

Group I
PlaceboOTHER

Neonates received placebo.

Group II

Eligibility Criteria

Age36 Weeks+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Pediatrics, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

July 21, 2025

First Posted

July 29, 2025

Study Start

January 1, 2023

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

July 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations

EG(1)