Melatonin for Neuroprotection Following Perinatal Asphyxia

Tanta University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Perinatal Asphyxia

Treatments: Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT02071160

01012012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: Under 6 hours old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups

Healthy Control

No Intervention group

Description:

A group of healthy control without any history suggestive of perinatal asphyxia or other diseases, are enrolled to compare different laboratory measurements

Hypothermia Group

No Intervention group

Description:

HIE infants who will not receive melatonin and only receive routine cooling protocol.

Melatonin/ hypothermia group

Experimental group

Description:

HIE infants who will receive melatonin in addition to the routine cooling protocol

Treatment:

Drug: Melatonin