Clinical Trial: Melatonin for Neuroprotection Following Perinatal Asphyxia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Melatonin for Neuroprotection Following Perinatal Asphyxia

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 Summary: 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.
Sponsor: Tanta University

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Tanta University

Dates:
Date Received: February 23, 2014
Date Started: January 2012
Date Completion:
Last Updated: February 23, 2014
Last Verified: February 2014