Melatonin for Neuroprotection Following Perinatal Asphyxia

Phase 2CompletedNCT02071160

Tanta University45 enrolled

Overview

The aim of this study is to examine the effect of combining melatonin to whole body cooling on the brain injury and outcome of neonates following perinatal asphyxia.

This is a prospective study on 30 neonates with moderate to moderately to severe hypoxic ischemic encephalopathy (HIE) . HIE infants are randomized into two groups: Whole body cooling group (N = 15; receive 72 hours of whole body hypothermia) and melatonin/ hypothermia group (N = 15; receive hypothermia and 5 daily enteral doses of melatonin 10 mg/kg). Serum melatonin, plasma superoxide dismutase (SOD),and serum nitric oxide (NO) are measured at enrollment and after 2 weeks for the two HIE groups. The HIE groups underwent electroencephalography at enrollment and at 2 to 3 weeks. Brain MRI was performed after 2 weeks of life. Neurologic evaluations and Denver Developmental Screening Test II assessments were performed at 6 months. A group of healthy newborns will be used as a control for baseline labs.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Perinatal Asphyxia

Interventions

MelatoninDRUG

Melatonin is administered to the melatonin/hypothermia group (n=15) in a dose of 10 mg/kg daily for a total of 5 doses starting immediately at enrollment. Melatonin tablets (1 or 3 mg/tablet) (Puritan's Pride,Oakdale, NY, USA) are crushed, then dissolved in 5-10 ml of distilled water , then administered via an orogastric tube.

Eligibility

Sex: ALLMax age: 6 HoursHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Inborn infants at term gestation (38-42 weeks) * Apgar scores ≤ 3 at 5 minutes and/or delayed first breath (\>5 minutes after birth) * Profound metabolic or mixed acidosis with serum bicarbonate levels of \<12 mmol/L in initial blood gas analyses * Evidence of moderate or moderate to severe encephalopathy, such as lethargy, seizures, abnormal reflexes, or hypotonia, in the immediate neonatal period Exclusion Criteria: * Twin gestation * Maternal neuro-endocrinal disturbances including diabetes mellitus * Chorioamnionitis or congenital infections * Low birth weight less than 2.5 kg * Congenital malformations of the central nervous system or gastrointestinal anomalies * Chromosomal abnormalities * After 6 hours of birth. * Patients in extremis such as: (1) hypoxemia requiring supplemental oxygen 100% FiO2, (2) life threatening coagulopathy, or (3) deep coma.

Locations (1)

Tanta University Children's Hospital

Tanta, Gharbia Governorate, Egypt

Outcomes

Primary Outcomes

Serum melatonin concentration (pg/ ml)

Time frame: 5 days

Plasma superoxide dismutase (SOD) activity (U/ml)

Time frame: 5 days

Serum nitric oxide (NO) concentrations (µmol/L)

Time frame: 5 days

Secondary Outcomes

Incidence of EEG abnormalities

Time frame: 2 weeks

Incidence of MRI abnormalities

Time frame: 2 weeks

Incidence of abnormal neurological examination

Time frame: 6 months

Incidence of abnormal Denver Developmental Screening Test II

Time frame: 6 months

Data from ClinicalTrials.gov

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