NCT03806816

Use of Melatonin for Neuroprotection in Asphyxiated Newborns

Use of Melatonin for Neuroprotection in Term Infants With Hypoxic-ischaemic Encephalopathy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital of Ferrara · Academic / Other
• Sex: All
• Age: 1 Hour – 6 Hours
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hypoxic-Ischemic Encephalopathy
• Cell Damage
• Asphyxia Perinatal

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Melatonin	5 daily enteral doses of melatonin 10 mg/kg. (=2 ml/kg)
OTHER	PLACEBO group	5 daily enteral doses of placebo 2 ml/kg

Timeline

• Start date: 2018-12-13
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2019-01-16
• Last updated: 2019-10-11

Locations

6 sites across 2 countries: Holy See, Italy