Melatonin for Neuroprotection Following Perinatal Asphyxia

Phase 1

Completed

• Conditions: Perinatal Asphyxia
• Interventions: Drug: Melatonin

• Registration Number: NCT02071160
• Lead Sponsor: Tanta University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2012-01
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-02
• Study First Submitted: 2014-02-23
• Study First Submitted QC: 2014-02-23
• Last Update Submitted: 2014-02-23
• Study First Posted: 2014-02-25
• Last Update Posted: 2014-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin/ hypothermia group	Melatonin	HIE infants who will receive melatonin in addition to the routine cooling protocol

Primary Outcome Measures

Name	Time	Method
Serum melatonin concentration (pg/ ml)	5 days
Plasma superoxide dismutase (SOD) activity (U/ml)	5 days
Serum nitric oxide (NO) concentrations (µmol/L)	5 days

Secondary Outcome Measures

Name	Time	Method
Incidence of EEG abnormalities	2 weeks
Incidence of MRI abnormalities	2 weeks
Incidence of abnormal neurological examination	6 months
Incidence of abnormal Denver Developmental Screening Test II	6 months

Trial Locations

Locations (1)

Tanta University Children's Hospital; 🇪🇬 Tanta, Gharbeya, Egypt