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Double-blind placebo-controlled trial of omeprazole in irritable infants with gastroesophageal reflux

David John Moore1, Billy Siang-Kuo Tao, David Robin Lines

  • 1Centre for Paediatric and Adolesent Gastroenterology, Women's and Children's Hospital, North Adelaide, SA 5006, Australia. moored@wch.sa.gov.au

The Journal of Pediatrics
|September 13, 2003
PubMed

Insights

Omeprazole effectively reduced esophageal acid exposure in irritable infants, but did not significantly decrease irritability symptoms. Infant irritability improved over time irrespective of treatment, suggesting a time-dependent resolution.

Area of Science:

  • Pediatric Gastroenterology
  • Pharmacology
  • Infant Health

Background:

  • Gastroesophageal reflux and esophagitis are common causes of irritability in infants.
  • Effective treatment options for irritable infants with these conditions are crucial.

Purpose of the Study:

  • To evaluate the efficacy of omeprazole in managing irritability in infants diagnosed with gastroesophageal reflux and/or esophagitis.
  • To compare omeprazole's effect on esophageal acid exposure and infant irritability against a placebo.

Main Methods:

  • A randomized, double-blind, placebo-controlled crossover trial was conducted with 30 irritable infants (3-12 months).
  • Infants had confirmed esophageal acid exposure (>5%) and/or abnormal esophageal histology.
  • Data on infant crying/fussing and parental assessment of irritability were collected over a 4-week period.

Main Results:

  • Omeprazole significantly reduced the esophageal reflux index compared to placebo (P<.001).
  • Infant cry/fuss time decreased from baseline during the study, irrespective of treatment sequence (P<.04 and P<.008).
  • No significant difference in irritability measures was observed between omeprazole and placebo treatment periods.

Conclusions:

  • Omeprazole effectively reduced esophageal acid exposure in irritable infants.
  • However, omeprazole did not demonstrate a significant benefit in reducing infant irritability compared to placebo.
  • Infant irritability improved over the 4-week study period, independent of the omeprazole treatment.
Abstract

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