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NCT Number: NCT07305350

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hypoxic Ischaemic Encephalopathy (HIE) Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

1 hour and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children Hospital and University of Child Health Sciences, Lahore

Lahore, Punjab Province, 05411, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Melatonin

Drug

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.

intravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic cover

Combination Product

55 neonates will be assigned group B in which patients will be given standard supportive therapy only.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
Dec 26, 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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