Observational studyBMJ paediatrics open2026
Clinical profile of gastro-oesophageal reflux disease and associated comorbidities in children aged 1-60 months: a prospective observational study.
Observational study in BMJ paediatrics open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundGastro-oesophageal reflux disease (GERD) in young children causes troublesome symptoms and complications affecting growth, feeding and quality of life, but symptom-based diagnosis correlates poorly with objective reflux severity. Contemporary clinical-profile data from South Indian children under 5 years and the accompanying nutritional and comorbidity burden are sparse.
methodsProspective observational study at a tertiary-care paediatric centre in South India (June 2023 to March 2025). Children aged 1-60 months with clinically suspected GERD were enrolled consecutively. Clinical profile, radionuclide gastro-oesophageal reflux (GER) scintigraphy grade, Indian Academy of Paediatrics weight-for-age nutritional status and confirmed comorbidities were documented; physiological reflux was distinguished from pathological GERD by predefined operational criteria (troublesome symptoms beyond 8 weeks plus at least one ESPGHAN and NASPGHAN red flag plus a scintigraphy grade of mild or above). Univariable logistic regression identified predictors of severe reflux and of no clinical improvement at follow-up. A prespecified sensitivity analysis was restricted to the 128 children with a positive scintigraphy result.
resultsOf 158 children, 40.5% (95% CI 33.2% to 48.3%) were aged 1-6 months and 62.0% (95% CI 54.3% to 69.2%) were male. Extraoesophageal respiratory symptoms predominated (cough 76.6%, 95% CI 69.4% to 82.5%; wheezing 67.1%), exceeding vomiting (48.7%). GER scintigraphy showed severe reflux in 35.4% (95% CI 28.4% to 43.2%), mild 29.7%, moderate 15.8% and normal 19.0%. Severe reflux clustered in younger infants (median age 4 vs 12 months in mild reflux; Kruskal-Wallis p<0.05). Protein-energy malnutrition was present in 39.9% (95% CI 32.6% to 47.7%) and any comorbidity in 81.0% (95% CI 74.2% to 86.4%), predominantly respiratory (recurrent wheezing 45.3%, bronchiolitis 18.8%, recurrent pneumonia 10.9%, asthma 6.3%). Symptom severity did not correspond to scintigraphic grade (χ
conclusionsIn this tertiary-referral cohort of South Indian children under 5 years, GERD predominantly affected young infants with a respiratory-dominant symptom profile and a high burden of protein-energy malnutrition and respiratory comorbidity. Objective scintigraphy severity was independently prognostic of treatment non-response despite the absence of a symptom-severity correlation. The findings support structured nutritional and comorbidity screening, targeted objective diagnostic evaluation using the ESPGHAN and NASPGHAN red-flag criteria, and caution against reflexive empirical acid suppression; the tertiary-referral design limits generalisability to primary-care populations.
trial registrationCTRI/2023/07/055893.
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