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Safety and efficacy of proton pump inhibitors in preterm infants with gastroesophageal reflux disease

King E, Horn D, Gluchowski N, O'Reilly D, Bruschettini M, Cooper C, Soll RF

The Cochrane database of systematic reviews, 2025

62 participants · 4 citations

Abstract

BACKGROUND

Although physiological reflux is seen in nearly all newborns to varying degrees, symptoms can be severe and cause gastroesophageal reflux disease (GERD). In preterm infants, one symptom that is often attributed to GERD is apnea and associated cardiorespiratory events, such as bradycardia and oxygen desaturation. Although the relationship between GERD and apnea, bradycardia, and desaturation events remains a subject of ongoing investigation, trials of agents that reduce gastric acidity, such as proton pump inhibitors (PPI), have been conducted to assess the effect of these agents on GERD.

OBJECTIVES

To assess the benefits and harms of PPIs for the treatment of preterm infants with diagnosed or suspected GERD.

SEARCH METHODS

We searched CENTRAL, MEDLINE, Embase, two trial registries, and Epistemonikos in October 2023. We checked reference lists of included studies, and studies and systematic reviews in which the subject matter was related to the intervention or population examined in this review.

SELECTION CRITERIA

We included randomized controlled trials, quasi-randomized controlled trials, cross-over trials, and cluster-randomized trials that assessed the use of PPIs (including esomeprazole, lansoprazole, omeprazole, pantoprazole, or rabeprazole) alone or in combination. Infants had to receive treatment for a minimum of three days. We considered the following comparisons: (1) PPIs versus no treatment, (2) PPI versus positioning changes (elevated head of bed or…

How strong is the evidence?

Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 62 participants or records.

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