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Erythromycin and Reflux Events in Premature Neonates

A Randomized Clinical Trial

Ballengee, Cortney R.*; Davalian, Faranek; Conaway, Mark R.; Sauer, Cary G.*; Kaufman, David A.

Journal of Pediatric Gastroenterology and Nutrition: December 2018 - Volume 67 - Issue 6 - p 720–725
doi: 10.1097/MPG.0000000000002086
Clinical Trials: Gastroenterology

Objective: Gastroesophageal reflux disease (GERD) in premature neonates may manifest as apnea, bradycardia, growth failure, aspiration, or feeding intolerance. Erythromycin ethylsuccinate (EES), is often used as a pro-kinetic in the management of GERD, despite lack of evidence or safety from randomized controlled trials. We sought to study the efficacy of enteral EES at a dose of 50 mg · kg−1 · day−1 in decreasing the frequency of gastroesophageal reflux events as determined by pH-multichannel intraluminal impedance (pH-MII) monitoring.

Methods: In a randomized, double-blind, placebo-controlled trial, eligible premature neonates with clinical signs of GERD underwent 24-hour pH-MII monitoring. If >5 reflux events were identified on pH-MII, then subjects were randomized to receive either EES or placebo. Repeat 24-hour pH-MII was performed on day 7 of study treatment and compared to initial pH-MII.

Results: Forty-three premature neonates were enrolled. Of those, 31 neonates were randomized, 15 to EES and 16 to placebo with a median (IQR) pretreatment total reflux events per 24 hours of 23 (16–40) and 29 (12–40), respectively. Day 7 total events per 24 hours decreased by 4 events in the EES group to 19 (15–33) and by 10 events in the placebo group to 19 (11–26) (P = 0.09). There were no differences in pretreatment and day 7 acidic and nonacidic reflux, proximal reflux, total or percent reflux time, median or longest bolus clearance time, or nurse-reported apnea events between groups.

Conclusions: Enteral EES did not decrease reflux events on 24-hour pH-MII at the dose studied. Therefore, it may be ineffective in the treatment of GERD in premature neonates.

*Emory University, Atlanta GA

Pediatrix Medical Group, Seattle

University of Virginia, Charlottesville, VA.

Address correspondence and reprint requests to Cortney R. Ballengee, MD, Emory University, Department of Pediatrics, 2015 Uppergate Drive, Atlanta GA 30322 (e-mail:

Received 21 December, 2017

Accepted 24 May, 2018

All phases of this study were supported through grants obtained from The Gerber Foundation and Thrasher Research Fund. registration number: NCT 01825473.

The authors have no conflicts of interest relevant to this article to disclose.

© 2018 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,