Erythromycin and Reflux Events in Premature Neonates: A Randomized Clinical Trial

Area of Science:

• Neonatal Medicine
• Gastroenterology
• Pharmacology

Background:

• Gastroesophageal reflux disease (GERD) presents unique challenges in premature neonates, potentially causing apnea, bradycardia, and feeding intolerance.
• Erythromycin ethylsuccinate (EES) is frequently used as a pro-kinetic agent for GERD in neonates, despite limited evidence from randomized controlled trials regarding its efficacy and safety.

Purpose of the Study:

• To evaluate the efficacy of enteral Erythromycin ethylsuccinate (EES) in reducing gastroesophageal reflux events in premature neonates.
• To assess the impact of EES on reflux frequency using pH-multichannel intraluminal impedance (pH-MII) monitoring.

Main Methods:

• A randomized, double-blind, placebo-controlled trial was conducted involving premature neonates with clinical signs of GERD.
• Participants underwent 24-hour pH-MII monitoring; those with >5 reflux events were randomized to receive either EES or placebo.
• Repeat pH-MII monitoring was performed on day 7 to compare reflux event frequency before and after treatment.

Main Results:

• Thirty-one premature neonates were randomized (15 to EES, 16 to placebo).
• No significant difference in the reduction of total reflux events per 24 hours was observed between the EES group (decrease of 4 events) and the placebo group (decrease of 10 events; P=0.09).
• No significant differences were found in acidic/nonacidic reflux, proximal reflux, reflux time, bolus clearance time, or reported apnea events between the groups.

Conclusions:

• Enteral Erythromycin ethylsuccinate at the studied dose (50 mg·kg·day) did not effectively decrease gastroesophageal reflux events in premature neonates as measured by pH-MII.
• The findings suggest that EES may not be an effective treatment for GERD in this vulnerable population.