Background: In infants, gastro-esophageal reflux is the physiological passage of gastric contents into the esophagus, with or without regurgitation. It is a very common phenomenon, spontaneously regressing around the age of 1 year. Gastro-esophageal reflux disease (GERD) is a pathological reflux defined by troublesome symptoms or complications, such as esophagitis. Treatment with proton pump inhibitors (PPIs) is not recommended unless the disease affects feeding, growth, or acquisition of developmental milestones. Although the use of these drugs is increasing, it has been little investigated in infants.
Objectives: To describe the frequency and characteristics of PPI use before the age of 1 year and its evolution over time.
Methods: This cohort study, based on the EPI-MERES register built from the French National Health Data System (SNDS), included children born in France between 2010 and 2021. PPI users were identified by a prescription reimbursed before 1 year old. Children with or without a hospital diagnosis of GERD were considered separately. Demographic and socioeconomic characteristics, medical characteristics, and healthcare use indicators were included in multivariate logistic regression models to assess factors associated with PPI use.
Results: Among a total of 8,222,100 children, 703,891 were PPI users (61,918 with hospital-diagnosed GERD and 641,973 without). The incidence of PPI use before 1 year old was 54.4 per 100 person-years among children with GERD (+33.6% between 2010 and 2021, from 43.1 to 57.6 per 100 person-years), and 7.9 per 100 person-years in those without (+63.6%, from 5.5 to 9.0 per 100 person-years). In children without hospital-diagnosed GERD, PPI use was independently associated with known risk factors for GERD (including extreme prematurity, adjusted odds ratio aOR 1.91 [95% CI 1.82-2.01]; digestive diseases, aOR 5.60 [5.49-5.71]; respiratory diseases, aOR 2.73 [2.70-2.75]; neurological diseases aOR 1.59 [1.56-1.62]) and with high maternal socioeconomic level (1st quintile of deprivation index [least deprived] vs 5th quintile [most deprived], aOR 1.80 [1.79-1.82]; monthly income ≥2,000 euros vs beneficiaries of the complementary solidarity health insurance, aOR 1.92 [1.91-1.94]).
Conclusions: The use of PPIs before 1 year old increased sharply between 2010 and 2021 in France, particularly in infants without hospital-diagnosed GERD. Beyond known risk factors for severe and chronic GERD (prematurity, digestive, respiratory or neurological diseases), PPI use was independently associated with maternal socioeconomic level, suggesting that non-medical factors could influence the prescription. Understanding determinants of prescribing is important to avoid unnecessary use of PPIs in infants.
