NCT07305350

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: University of Child Health Sciences and Children's Hospital, Lahore · Academic / Other
• Sex: All
• Age: 1 Hour
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hypoxic Ischaemic Encephalopathy (HIE)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-10
• Primary completion: 2026-05-10
• Completion: 2026-05-10
• First posted: 2025-12-26
• Last updated: 2025-12-26

Locations

1 site across 1 country: Pakistan