Comparison of Effectiveness in Two Different Oral Erythromycin Dose Regimen for Treatment of Feeding Intolerance in Preterm Infants

Han, Seong Woo; Jeon, Ga Won; Sin, Jong Beom

Abstract

PURPOSE
The objective of this study was to compare the effectiveness and safety of intermediate dose oral erythromycin treatment for feeding intolerance in preterm infants with high dose oral erythromycin regimen.
METHODS
A prospective, randomized study in a tertiary referral center of a university hospital was conducted on 40 preterm infants less than 1,500 g, diagnosed as feeding intolerance. The infants were randomly allocated to receive high dose oral erythromycin (12.5 mg/kg, every six hours for 14 days) or intermediate dose erythromycin (10 mg/kg, every 6 hours for the first 2 days, followed by 4 mg/kg, every 6 hours for another 5 days). The times taken to establish full enteral feeding and the numbers of withheld feeds after the drug treatment were compared between the two groups. Potential adverse effects of oral erythromycin and complications associated with parenteral nutrition were assessed as secondary outcomes.
RESULTS
Baseline characteristics were similar between the two groups. There was no significant difference in times to full feeding (40.4 days in high dose group and 38.6 days in intermediate dose group) and numbers of withheld feeding (3.1 in high dose group and 2.8 in intermediate dose group). No significant differences in episodes of sepsis, necrotizing enterocolitis, cholestasis and death were observed between two groups. No episode of arrhythmia and hypertrophic pyloric stenosis were observed in both group. Noninferiority was demonstrated of intermediated dose regimen for efficacy and adverse effect of erythromycin, compared with high dose regimen.
CONCLUSION
Intermediate dose oral erythromycin treatment does improve feeding intolerance in preterm infants as effectively and safely as high dose erythromycin treatment regimen.