investigating the effect of melatonin on short-term prognosis of neonatal hypoxic-ischemic encephalopathy: a randomized controlled trial

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.