Oral Melatonin as Neuroprotectant in Preterm Infants
Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
Summary
Preterm newborns survival rates are improved, but long-term disabilities are still common.
Major destructive focal lesions became less common, the most predominant lesion at present is
diffuse white matter (WM damage). Melatonin (ME) serves as a neuroprotectant cerebral
ischemia through its potent anti-oxidant/-inflammatory effect. Preclinical studies
demonstrated that protects the developing brain by preventing abnormal myelination and
inflammatory glial reaction. Clinical studies demonstrated ME ability in reducing brain
damage after neonatal Hypoxic Ischemic Encephalopathy (HIE) or preventing neonatal
impairments due to antenatal/ post-natal injuries: preeclampsia,
IntraUterineGrowthRestriction (IUGR), ventilation, Bronchopulmonary Dysplasia (BPD). ME has a
good safety profile with no known adverse effects. This study aims to highlight that ME can
prevent brain impairment due to premature birth. ME will be administered orally (3 mg/kg/die
for 15 days to neonates born before 29+6 week gestation, in a prospective double blind,
randomized vs placebo study, 2 parallel arms. ME and malondialdehyde (MDA), a lipid
peroxidation product) levels before and at the end of treatment will be measured . Other
outcomes: Cerebral ultrasounds (cUS); cerebral magnetic resonance imaging (cMRI), " Fagan
test " eye tracking, ophthalmological, auditory, neurological/cognitive child assessments.
Monitoring parental distress, which can influence the neurodevelopmental outcome in preterms.
Phase:
N/A
Details
Lead Sponsor:
Francesca Garofoli
Collaborators:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia IRCCS National Neurological Institute "C. Mondino" Foundation University of Pavia