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Use of Melatonin for Neuroprotection in Asphyxiated Newborns

NCT03806816 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-10-11

No results posted yet for this 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.

Conditions

  • Hypoxic-Ischemic Encephalopathy
  • Cell Damage
  • Asphyxia Perinatal

Interventions

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

Sponsors & Collaborators

  • AUSL Romagna Rimini

    collaborator OTHER

  • University Hospital of Ferrara

    lead OTHER

Principal Investigators

  • Anna Tarocco, MD · University Hospital of Ferrara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
6 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-13
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • Holy See
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03806816 on ClinicalTrials.gov