Melatonin for Neuroprotection Following Perinatal Asphyxia

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tanta University
• Treatments: Melatonin

Criteria

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.