What is the efficacy of Esomeprazole (generic name) for Gastroesophageal Reflux Disease (GERD) in premature infants?

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Last updated: March 2, 2025View editorial policy

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From the Guidelines

Esomeprazole should be used with caution in premature infants with gastroesophageal reflux disease (GERD), as the benefits of treatment must be carefully weighed against the potential risks, including increased risk of necrotizing enterocolitis, infections, and altered gut microbiome 1.

Recommended Approach

When considering the use of esomeprazole in premature infants for GERD, it is essential to start with a thorough assessment of the infant's symptoms and medical history. The recommended dosage, based on the most recent and highest quality evidence, is not explicitly stated for premature infants, but for infants in general, the dosage range is 0.7-3.3 mg/kg/d, as indicated in studies such as 1 and 1. However, given the potential risks associated with proton pump inhibitors in this vulnerable population, initiating treatment at the lower end of the dosage range (e.g., 0.5 mg/kg/day) is advisable, with careful monitoring and potential adjustment based on clinical response.

Non-Pharmacological Interventions

Before initiating esomeprazole or any pharmacological treatment, non-pharmacological approaches should be tried first, including:

  • Smaller, more frequent feedings
  • Proper positioning after feeds (left lateral or prone position under supervision)
  • Thickened feeds if appropriate, though with caution in preterm infants due to the risk of necrotizing enterocolitis, as noted in 1

Monitoring and Reassessment

Careful monitoring for adverse effects is essential, and the risk-benefit ratio should be regularly reassessed throughout treatment. Treatment duration should be limited to the shortest period necessary, typically 2-4 weeks, with reassessment of symptoms to determine if continued therapy is needed.

Evidence Considerations

The evidence from studies such as 1, 1, and 1 highlights the importance of cautious use of esomeprazole in premature infants due to potential risks. While esomeprazole can be effective in reducing acid production and alleviating GERD symptoms, the decision to use it in premature infants must be made with careful consideration of the potential benefits and risks, emphasizing the need for close monitoring and a tailored approach to each infant's care.

From the Research

Efficacy of Esomeprazole for GERD in Premature Infants

  • The provided studies do not specifically focus on premature infants, but rather on infants in general, with ages ranging from 1 to 24 months 2, 3, 4, 5, 6.
  • However, the studies suggest that esomeprazole is effective in reducing symptoms of GERD in infants, with significant improvements in symptom scores and acid reflux episodes 2, 4, 6.
  • A study published in 2015 found that esomeprazole was well tolerated and provided dose-related acid suppression in infants 1-24 months old with GERD 6.
  • Another study published in 2013 discussed the treatment of GERD in infants, including the use of esomeprazole, but did not provide specific data on premature infants 3.
  • A 2023 review of pharmacological treatments for GOR in infants and children found that esomeprazole appeared to show no additional reduction in the number of GORD symptoms compared to placebo in neonates, but the evidence was of very low certainty 5.
  • The studies suggest that improved diagnostic criteria are needed to identify infants with GERD who may benefit from acid suppression therapy, including esomeprazole 2, 4.

Key Findings

  • Esomeprazole is effective in reducing symptoms of GERD in infants, but the evidence is limited for premature infants specifically 2, 4, 6.
  • Esomeprazole is well tolerated in infants, with dose-related acid suppression and decreased esophageal acid exposure 6.
  • Further studies are needed to determine the efficacy and safety of esomeprazole in premature infants with GERD 2, 4, 5.

Study Limitations

  • The studies did not specifically focus on premature infants, which limits the applicability of the findings to this population 2, 3, 4, 5, 6.
  • The evidence for the efficacy of esomeprazole in neonates is of very low certainty, highlighting the need for further research 5.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Esomeprazole for the Treatment of GERD in Infants Ages 1-11 Months.

Journal of pediatric gastroenterology and nutrition, 2015

Research

Esomeprazole for the treatment of GERD in infants ages 1-11 months.

Journal of pediatric gastroenterology and nutrition, 2012

Research

Pharmacological treatment of gastro-oesophageal reflux in children.

The Cochrane database of systematic reviews, 2023

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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