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

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

Status and phase: Active, not recruiting; Phase 2

Conditions: Hypoxic Ischaemic Encephalopathy (HIE)

Treatments: Combination Product: intravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic cover; Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT07305350

No/779/CH-UCHS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 1+ hour old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Group A

Experimental group

Description:

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.

Treatment:

Drug: Melatonin

Group B

Active Comparator group

Description:

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

Treatment:

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