EFFICACY OF MELATONIN IN MANAGEMENT OF HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE) IN NEONATES

December 12, 2025 updated by: Dr. Amina Cheema, University of Child Health Sciences and Children's Hospital, Lahore
To compare the survival rate and improvement in stage of hypoxic ischemic encephalopathy (HIE) at day 7 of treatment in neonates treated with versus without melatonin in addition to standard supportive therapy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized control trial and the purpose of this study is to determine efficacy of melatonin in management of hypoxic ischemic encephalopathy in newborns. Baseline characteristics will be documented after which patients will be divided into two groups by paper lottery method namely group A in which newborns will be given single 10mg dose of melatonin through nasogastric tube in addition to standard supportive therapy and group B in which patients will be given standard supportive therapy only.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 05411
        • Children Hospital and University of Child Health Sciences, Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

All term infants (as per operational definition). Both genders. Presenting with hypoxic ischemic encephalopathy (as per operational definition).

Exclusion criteria:

Drug reactions. Newborns at gestational age < 36 weeks. Neonates whose mother received general anesthesia. Neonates with congenital malformations. Neonates whose mother received anticonvulsants. Neonates not fulfilling criteria for HIE. Neonatal sepsis, pneumonia or in-born error of metabolism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
55 neonates will be assigned group A in which newborns will be given single 10mg dose of melatonin through nasogastric tube in addition to standard supportive therapy.
Drug: Melatonin
55 neonates will be assigned group A in which newborns will be given single 10mg dose of melatonin through nasogastric tube in addition to standard supportive therapy.
Active Comparator: Group B
55 neonates will be assigned group B in which patients will be given standard supportive therapy only. Standard supportive therapy included oxygen therapy, intravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic cover for possible role of infection
Combination product: intravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic cover
55 neonates will be assigned group B in which patients will be given standard supportive therapy only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonate survival rate
Time Frame: 28 days of life
Role of melatonin will be determined primarily by survival rate in neonates with hypoxic ischemic encephalopathy at 28 days of life.
28 days of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in stage of HIE
Time Frame: Day 1, 3 and 7 of life
Secondary outcome measures to determine role will be improvement in stage of hypoxic ischemic encephalopathy (based on Thomson score) at day 1, 3 and 7.
Day 1, 3 and 7 of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Child Health Sciences and Children's Hospital, Lahore

Investigators

  • Study Chair: Muhammad Khalid Masood, MBBS, FCPS, Children Hospital and University of Child Health Sciences, Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2025

Primary Completion (Estimated)

May 10, 2026

Study Completion (Estimated)

May 10, 2026

Study Registration Dates

First Submitted

December 12, 2025

First Submitted That Met QC Criteria

December 12, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 12, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No/779/CH-UCHS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to confidentiality

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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