Investigating the Effect of Melatonin on Short-Term Prognosis of Neonatal Hypoxic-Ischemic Encephalopathy: A Randomized Controlled Trial

Nahid  Kiani; Maryam Shokouhi  Solgi; Mohammad Kazem  Sabzehei; Fatemeh  Eghbalian; Nasrin  Jiryaee; Behnaz  Basiri

doi:10.18502/acta.v64i1.21036

Nahid Kiani Department of Pediatrics, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran
Maryam Shokouhi Solgi Department of Pediatrics, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran
Mohammad Kazem Sabzehei Department of Pediatrics, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran
Fatemeh Eghbalian Department of Pediatrics, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran
Nasrin Jiryaee Department of Community Medicine, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran
Behnaz Basiri Department of Pediatrics, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran

DOI: https://doi.org/10.18502/acta.v64i1.21036

Keywords: Neonates; Hypoxic-ischemic encephalopathy; Melatonin; Survival rate; Hospitalization

Abstract

Hypoxic-ischemic encephalopathy (HIE) is a leading cause of neonatal mortality with limited therapeutic options. This study evaluated the effect of melatonin on short-term outcomes in neonates with HIE. To determine whether adjunctive oral melatonin improves short-term clinical outcomes, including in-hospital survival, in neonates with HIE. A randomized controlled trial enrolled 80 neonates with HIE at Fatemieh Hospital, Hamadan, Iran (2021-2023). The intervention group (n=32) received standard treatment plus 10 mg/kg oral melatonin daily for 5 days, while the control group (n=48) received standard treatment alone. Outcomes included seizure frequency, hospital stay duration, time to initiate oral feeding, time to regain consciousness, adverse effects, and in-hospital survival. Baseline characteristics, HIE severity, medications for seizure control, and paraclinical/imaging findings were comparable between groups (all P>0.05). No significant adverse effects were observed. The intervention group had a higher survival rate (81.2%, 26/32) than the control group (52.1%, 25/48) (P=0.04). There were no significant differences in hospital length of stay, time to start feeding, or time to regain consciousness among surviving neonates (all P>0.05). Adjunctive melatonin may improve in-hospital survival in neonates with HIE and merits further evaluation as an additive therapy.