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Randomized Clinical Trial of Metoclopramide as Prophylaxis of Gastroesophageal Reflux Disease in Preterm Infants

Adriana Del Pilar Montealegre-Pomar1,2, Nathalie Charpak3

  • 1Pediatrics Department, Pontificia Universidad Javeriana, Carrera 7 No 40-62, Bogotá, Colombia. montealegre.a@javeriana.edu.co.

Paediatric Drugs
|October 25, 2021
PubMed

Insights

Metoclopramide did not effectively prevent gastroesophageal reflux disease symptoms in premature infants. This study found no significant difference in GERD symptoms or side effects between metoclopramide and placebo groups.

Area of Science:

  • Neonatal Medicine
  • Pediatric Gastroenterology
  • Clinical Pharmacology

Background:

  • Gastroesophageal reflux (GER) is common in premature infants.
  • Metoclopramide was previously used for GER prophylaxis in this population.
  • Recent concerns regarding metoclopramide safety in children prompted this investigation.

Purpose of the Study:

  • To evaluate the effectiveness of metoclopramide for gastroesophageal reflux disease (GERD) prophylaxis in premature infants.
  • To assess the safety profile of metoclopramide when used for GERD prophylaxis in this vulnerable population.

Main Methods:

  • A randomized, double-blind, placebo-controlled trial involving 466 premature infants.
  • Infants received either metoclopramide (0.2 mg/kg thrice daily) or placebo until term.
  • GERD symptoms and adverse events were monitored weekly by parents.

Main Results:

  • No clinically significant differences in GERD-related symptoms were observed between the metoclopramide and placebo groups.
  • The incidence of both minor and severe side effects did not differ significantly between the groups.
  • The study found no evidence of metoclopramide's effectiveness in preventing GERD symptoms.

Conclusions:

  • Systematic use of metoclopramide is ineffective for GERD symptom prophylaxis in premature infants.
  • No adverse effects attributable to metoclopramide were identified in this study.
  • Findings suggest reconsidering routine metoclopramide use for GERD prophylaxis in preterm neonates.
Abstract

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