Hypoxic-Ischemic Encephalopathy Clinical Trial
Official title:
Use of Melatonin for Neuroprotection in Term Infants With Hypoxic-ischaemic Encephalopathy
Protection of brain development is a major aim in the Neonatal Intensive Care Unit.
Hypoxic-Ischemic Encephalopathy (HIE) occurs in 3-5 per 1000 births. Only 47% of neonates
have normal outcomes. The neurodevelopmental consequences of brain injury for asphyxiated
term infants include cerebral palsy, severe intellectual disabilities and also a number of
minor behavioural and cognitive deficits. However, there are very few therapeutic strategies
for the prevention or treatment of brain damage. The gold standard is hypothermic treatment
but, according to the literature, melatonin potentially acts in synergy with hypothermia for
neuroprotection and to improve neurologic outcomes. Melatonin appears to be a good candidate
because of its different protective effects including reactive oxygen species scavenging,
excitotoxic cascade blockade, modulation of neuroinflammatory pathways.
The research study will evaluate the neuroprotective properties and the effects of Melatonin
in association with therapeutic hypothermia for hypoxic ischemic encephalopathy.
It is a randomized double blind, placebo controlled trial on 100 neonates with moderate to
moderately to severe hypoxic ischemic encephalopathy (HIE) . HIE infants are randomized into
two groups: Whole body cooling group (N = 50 receive 72 hours of whole body hypothermia) and
melatonin/ hypothermia group (N = 50; receive hypothermia and 5 daily enteral doses of
melatonin 10 mg/kg). Serum melatonin and autophagy levels are measured at enrollment, daily
during the hypothermic treatment, at day 5 and 7 for the two HIE groups.
aEEG will be performed for 72 hrs during the hypothermic treatment and the re-warming. MRI
and Spectroscopy analysis will be performed between day 5 and 7 of. After hospital discharge
the infants will enter a follow-up program consisting in periodic clinical and developmental
assessments until 2 years of age corrected for prematurity. An expert psychologist and a
neonatologist will assess neurodevelopmental outcome using the Bayley Scales III at 6-12-24
months of corrected age.
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