NCT03806816: MELPRO

Use of Melatonin for Neuroprotection in Asphyxiated Newborns

Status unknown NA Last updated 11 October 2019

What this trial tests

NA trial testing Melatonin in Hypoxic-Ischemic Encephalopathy in 100 participants. Status unknown.

Timeline

13 December 2018

Primary endpoint
31 December 2021

31 December 2022

Quick facts

Lead sponsor	University Hospital of Ferrara
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	13 December 2018
Primary completion	31 December 2021
Estimated completion	31 December 2022
Sites	6 locations across Holy See, Italy

Drugs / interventions tested

• Melatonin (MELATONIN) — full drug profile →
• PLACEBO group

Conditions studied

• Hypoxic-Ischemic Encephalopathy — all drugs for Hypoxic-Ischemic Encephalopathy →
• Cell Damage — all drugs for Cell Damage →
• Asphyxia Perinatal — all drugs for Asphyxia Perinatal →

Sponsor

University Hospital of Ferrara

Who can join

Adults 1 Hour to 6 Hours, any sex, with Hypoxic-Ischemic Encephalopathy or Cell Damage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

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

1. Neuroprotective therapies in the NICU in term infants: present and future.
   Molloy EJ, El-Dib M, Juul SE, Benders M, et al · · 2023 · cited 61× · PMID 36195634 · DOI 10.1038/s41390-022-02295-2
2. Advances in Therapies to Treat Neonatal Hypoxic-Ischemic Encephalopathy.
   Ranjan AK, Gulati A. · · 2023 · cited 41× · PMID 37892791 · DOI 10.3390/jcm12206653
3. Ferroptosis: A Promising Therapeutic Target for Neonatal Hypoxic-Ischemic Brain Injury.
   Peeples ES, Genaro-Mattos TC. · · 2022 · cited 41× · PMID 35806425 · DOI 10.3390/ijms23137420
4. An Assessment of Melatonin's Therapeutic Value in the Hypoxic-Ischemic Encephalopathy of the Newborn.
   Cardinali DP. · · 2019 · cited 35× · PMID 31920617 · DOI 10.3389/fnsyn.2019.00034
5. Comparing the efficacy in reducing brain injury of different neuroprotective agents following neonatal hypoxia-ischemia in newborn rats: a multi-drug randomized controlled screening trial.
   Sabir H, Maes E, Zweyer M, Schleehuber Y, et al · · 2023 · cited 25× · PMID 37301929 · DOI 10.1038/s41598-023-36653-9
6. Neonatal asphyxia as an inflammatory disease: Reactive oxygen species and cytokines.
   Okazaki K, Nakamura S, Koyano K, Konishi Y, et al · · 2023 · cited 16× · PMID 36776908 · DOI 10.3389/fped.2023.1070743
7. Neuroprotection for neonatal hypoxic-ischemic encephalopathy: A review of novel therapies evaluated in clinical studies.
   Chan NH, Hawkins CC, Rodrigues BV, Cornet MC, et al · · 2025 · cited 8× · PMID 39563426 · DOI 10.1111/dmcn.16184
8. Pharmacological Therapies for Consequences of Perinatal Hypoxic-Ischemic Brain Injury: Where Are We Now?
   Gebala P, Janowska J, Sypecka J. · · 2025 · PMID 41155490 · DOI 10.3390/ijms262010200