the effect of melatonin on the immune system and the treatment of neonatal sepsis

Introduction:neonatal sepsis is a leading cause of morbidity and mortality, particularly in preterm infants, involving systemic inflammation and oxidative stress. melatonin, with its antioxidant, anti-inflammatory, and immunomodulatory properties, has emerged as a potential adjuvant to standard antibiotic therapy. this systematic review and meta-analysis synthesizes evidence from randomized controlled trials (rcts) and clinical studies from 2000 to 2025 evaluating melatonin's efficacy and safety in neonatal sepsis.materials and methods:databases including pubmed, embase, cochrane library, web of science, scopus, and clinicaltrials.gov were searched for rcts and trials on melatonin as adjuvant in neonatal sepsis. inclusion: studies 2000-2025, neonates (<28 days), confirmed sepsis, melatonin vs. control (antibiotics alone). outcomes: biomarkers (c-reactive protein or crp, malondialdehyde or mda, interlukine or il-6/8), sepsis scores, mortality, hospital stay, adverse events.results:nine rcts (n=354 neonates) included. melatonin (typically 20 mg oral, single or divided) reduced crp at 24h (p<0.001) and mda (p<0.001). improved sepsis recovery at 72h (p<0.001). mortality lower (p<0.001), no adverse events. preterm subgroup showed enhanced benefits.conclusions:melatonin improves biomarkers and outcomes in neonatal sepsis safely, but larger rcts needed for confirmation and dosing.