Use of Melatonin for Neuroprotection in Asphyxiated Newborns

Last updated: October 10, 2019
Sponsor: University Hospital of Ferrara
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Ischemia

Stroke

Cerebral Palsy

Treatment

N/A

Clinical Study ID

NCT03806816
23/2018/SPER/AOUFE
  • Ages < 6
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • gestational age > 35 weeks and weight > 1800 gr

  • Apgar score < 5 at 10 minutes o need for cardiopulmonary resuscitation at 10 minutesor evidence of base excess > 12 mmol/L or pH < 7,0 at initial blood gas analyses

  • evidence of moderate or severa encephalopathy graded according to Sarnat&Sarnatneurological evaluation

  • abnormal amplitude integrated electroencephalography

Exclusion

Exclusion Criteria:

  • suspected inborn errors of metabolism

  • major chromosomal congenital defects

Study Design

Total Participants: 100
Study Start date:
December 13, 2018
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • Ospedale Pediatrico Bambin Gesù

    Vatican City,
    Holy See (Vatican City State)

    Active - Recruiting

  • ospdale di Bolzano

    Bolzano,
    Italy

    Active - Recruiting

  • Bufalini Hospital Cesena

    Cesena,
    Italy

    Active - Recruiting

  • University Hospital "Sant'Anna" of Ferrara

    Ferrara, 44124
    Italy

    Active - Recruiting

  • ospedale San Salvatore

    L'Aquila,
    Italy

    Active - Recruiting

  • Infermi Hospital Rimini

    Rimini, 47923
    Italy

    Active - Recruiting

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