Role of oral erythromycin for feed intolerance in neonates - A randomized controlled trial
Journal Title: Indian Journal of Child Health - Year 2018, Vol 5, Issue 6
Abstract
Objective: The objective of this study was to compare the effect of high and low dose of erythromycin with placebo and to determine the efficacy and safety of oral erythromycin for feed intolerance in neonates admitted to the neonatal intensive care unit. Methodology: The study was a double-blind, randomized, and placebo-controlled trial. Term and preterm babies having feed intolerance were included in the study, and babies with congenital malformations, necrotizing enterocolitis, and sepsis were excluded from the study. After parental consent, the subjects were randomized into Groups 1, 2, or 3 to receive low-dose (3 mg/kg/dose) or high-dose (10 mg/kg/dose) oral erythromycin estolate or the placebo (equal volume of 5% dextrose). Feeding of all the study neonates was managed as per the unit protocol and babies were monitored for the complications. The primary outcome was the time to reach full feeds of 150 ml/kg/day, without significant gastric residuals. Results: Of 58 eligible babies, 84.5% were preterm babies. The median time for reaching full feeds with placebo was 6 days with interquartile range 3–4 days, for high dose was 4 (3–7) days and for low dose 6 (4.3–7) days (p=0.47). The total duration of erythromycin for placebo, high-dose, and low-dose group was median days 11 (7–14), 9 (7–13), and 9 (7–14), respectively, with p=0.86. There was no difference in the incidence of raised liver enzymes, vomiting, sepsis, and need for intravenous fluids, total parenteral nutrition, and duration of hospital stay between the groups. None of the babies had adverse events such as fatal arrhythmias and pyloric stenosis. Conclusion: There was no significant difference in the time to reach full feeds after erythromycin and the duration of study medication between the high‑dose and low-dose erythromycin with the placebo group. No adverse effects were seen in any of the groups.
Authors and Affiliations
Chandrakala Bada Shekharappa, Swarnarekha Bhat, Ashok Chandrasekaran
Keywords
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