Efficacy of low dose oral erythromycin for treatment of feeding intolerance in preterm infants : a randomized controlled trial

Abstract

Objectives: To determine efficacy and safety of low dose oral erythromycin for treatment of feeding intolerance in preterm infants less than 35 weeks of gestation or birth weight less than 1800 g. Study design: A randomized, double-blinded, placebo controlled trial. Setting: Ramathibodi Hospital, Srinagarind Hospital, and Chiang-Mai University Hospital Research Methodology: Preterm infants with feeding intolerance were randomly allocated to treatment group or placebo group. The treatment group received erythromycin ethyl succinate for 7 days. Placebo group received manufactured placebo with similar appearance. The primary outcome was time to full enteral feeding after enrollment (150 ml/kg/day). Secondary outcomes included duration of parenteral nutrition, catheter related complications and side effects related to the medication in this study. Results: Forty-six infants were enrolled: 23 in erythromycin group (EM) and 23 in placebo group. Baseline characteristics were similar between groups including gestational age 1 birth weight, Apgar scores, severity of respiratory status, feeding volume at enrollment, and age at enrollment. Time to full enteral feeding was significantly shorter in EM group with a median of 7 days (interquartile ranges; IQR of 6,9 days) than that of placebo with a median of 13 days (IQR,9,15days), p<0.001. Duration of parenteral nutrition was also significantly shorter in EM group with a median of 13 days (IQR; 11,15) as compared to 17 days (IQR; 13,25) in placebo group, p = 0.03. Significant reduction in numbers of holding feeds or gastric residuals of more than 50 percent were observed in EM group. There were no significant differences in episodes of sepsis, necrotizing enterocolitis and cholestasis. One infant in treatment died of NEC stage III, but 11 days after discontinuing of erythromycin. Conclusions: Low dose oral erythromycin is effective for treatment of feeding intolerance in preterm infants by shortening time to full feeding. It also reduced the duration of parenteral nutrition and decreased numbers of significant gastric residuals. However, routine or prophylaxis used of erythromycin is not recommended. The results of this study warrant further study in larger scale clinical trial to confirm its efficacy and safety.