Oral Melatonin as Neuroprotectant in Preterm Infants

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Melatonin; Neuroprotective Agents

Criteria

Inclusion Criteria

• preterm newborns gestational age GA < 29+6 weeks + day

• able to receive min 20ml/kg/day enteral nutrition, within 96 hours from birth

• written informed consent by both the parents.

Exclusion Criteria:

• preterm newborns GA > 29+6 weeks + days

• not able to receive enteral nutrition (min 20 ml/kg/die) within 96 hours of life

• infants with genetic and/or congenital metabolic or chronic diseases

• intraventricular hemorrhage (IVH) ≥ III,

• parents refusing to sign a written informed consent