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

NCT07305350 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-12-26

No results posted yet for this study

Summary

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.

Conditions

  • Hypoxic Ischaemic Encephalopathy (HIE)

Interventions

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.

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2026-05-10
Completion
2026-05-10

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07305350 on ClinicalTrials.gov