NCT04235673

Oral Melatonin as Neuroprotectant in Preterm Infants

Completed NA Last updated 25 July 2024

What this trial tests

NA trial testing melatonin in Malondialdehyde in 60 participants. Completed in 11 October 2022.

Timeline

25 May 2020

Primary endpoint
1 October 2022

11 October 2022

Quick facts

Lead sponsor	Francesca Garofoli
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	60
Start date	25 May 2020
Primary completion	1 October 2022
Estimated completion	11 October 2022
Sites	4 locations across Italy

Drugs / interventions tested

• melatonin (MELATONIN) — full drug profile →
• placebo

Conditions studied

• Malondialdehyde — all drugs for Malondialdehyde →
• Melatonin — all drugs for Melatonin →

Sponsor

Francesca Garofoli

Who can join

Adults 25 Weeks to 30 Weeks, any sex, with Malondialdehyde or Melatonin. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Oxidative Stress in Preterm Infants: Overview of Current Evidence and Future Prospects.
   Falsaperla R, Lombardo F, Filosco F, Romano C, et al · · 2020 · cited 25× · PMID 32645921 · DOI 10.3390/ph13070145
2. Oral melatonin as a new tool for neuroprotection in preterm newborns: study protocol for a randomized controlled trial.
   Garofoli F, Longo S, Pisoni C, Accorsi P, et al · · 2021 · cited 10× · PMID 33482894 · DOI 10.1186/s13063-021-05034-w
3. Melatonin as a Therapy for Preterm Brain Injury: What Is the Evidence?
   Häusler S, Robertson NJ, Golhen K, van den Anker J, et al · · 2023 · cited 8× · PMID 37627625 · DOI 10.3390/antiox12081630
4. Enteral Bioactive Factor Supplementation in Preterm Infants: A Systematic Review.
   Mank E, Naninck EFG, Limpens J, van Toledo L, et al · · 2020 · cited 7× · PMID 32987621 · DOI 10.3390/nu12102916
5. Early Oral Melatonin Supplementation Supports White Matter Maturation in Preterm Infants: Neuroprotective Insights of an Antioxidant Molecule.
   Garofoli F, Asteggiano C, Minniti ML, Accorsi P, et al · · 2026 · PMID 42138165 · DOI 10.1111/jpi.70147
6. Preterm graduates from the neonatal intensive care unit and future adult cardiac problems: A narrative review.
   Rakesh K. · · 2025 · PMID 41743529 · DOI 10.4103/apc.apc_175_25