Melatonin as an adjuvant therapy in preterm infants with neonatal sepsis, randomized trial

Abstract

Background: Neonatal sepsis (NS) is a systemic uncontrolled inflammatory response to an infectious agent, resulting in oxidative stress. Melatonin antioxidant and free radical scavenger proved to be safe in neonates. We aimed to evaluate the efficacy and safety of melatonin as adjuvant therapy in NS. This was an interventional trial conducted on 40 preterm neonates with NS diagnosed on the basis of clinical and laboratory criteria. They were simply randomized to melatonin treated (MT) (n = 20) and conventionally treated (CT) (n = 20) groups. Melatonin was administered at a total dose of 20 mg enterally in two divided doses of 10 mg each, 1 h apart. Malondialdehyde (MDA) was assessed in patients at enrollment, 4 and 72 h later in MT, and 72hours later in CT. Fifteen healthy matched neonates were included as a control. Results: There were no significant differences between MT and CT groups regarding baseline sepsis workup. However, total leucocytic count, absolute neutrophil count, and C-reactive protein were significantly higher and platelets were significantly lower in CT compared to MT after 72 h. MDA was doubled in CT while reduced in MT 72 h after intervention (p = 0.000). Mortality was significantly lower in MT. No side effects following melatonin administration were reported. Conclusion:Melatonin is effective and safe adjuvant for treatment of NS that improves clinical and laboratory outcomes.

Enteral Bioactive Factor Supplementation in Preterm Infants: A Systematic Review

“…Five trials (19%) were judged as with an overall high risk of bias, based on various subdomains ( Figure 2 ) [ 21 , 25 , 26 , 31 , 44 ]. Risk of bias assessment revealed some concerns for 13 trials (50%), as they were not preregistered in trial registries, and no predefined statistical analysis plan and/or study protocol was published for these studies, which precluded selective data reporting judgement.…”

“…The effects of any hormone or growth factor as therapeutic supplement in preterm infants was assessed in two studies [ 25 , 26 ]. The first study, by El-Kabbany et al [ 25 ], was conducted in 40 preterm infants (GA < 36 weeks) with early or late-onset sepsis (based on clinical signs and laboratory indicators including Rodwell’s hematological score ≥3). Participants received a single dose of melatonin (20 mg) or placebo.…”

Evaluation of Red Blood Cell Distribution Width in Newborns with Neonatal Sepsis

“…Neonatal sepsis (NS) is a main source of neonatal dreariness and mortality and a significant general medical issue, particularly in creating nations and especially in pre-term babies [14].…”

Influence of innate immune activation on endocrine and metabolic pathways in infancy

“…In addition to its important role as an antioxidant, a recent study has illustrated the importance of melatonin in glucose regulation, improving sepsis-induced hyperglycemia in an animal model (180). Exogenous melatonin as adjunctive therapy for sepsis in preterm and term infants has been associated with improvements in laboratory and clinical outcomes, due to the leading role of oxidative stress in pathogenesis of preterm morbidity and sepsis (181)(182)(183)(184)(185)(186)(187). In support of its amelioration in sepsis, a recent clinical trial has demonstrated improved patient outcomes when melatonin was used as an adjunctive therapy in adult sepsis (188).…”