Clinical profile of gastro-oesophageal reflux disease and associated comorbidities in children aged 1-60 months: a prospective observational study.

BACKGROUND: Gastro-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. METHODS: Prospective 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. RESULTS: Of 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 (χ2 p=0.40). Among 78 children with follow-up, severe reflux independently predicted no clinical improvement compared with mild reflux (OR 4.00, 95% CI 1.01 to 15.77, Fisher exact p=0.047). Every principal finding was reproduced in the confirmed-GERD sensitivity analysis (n=128). CONCLUSIONS: In 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 REGISTRATION: CTRI/2023/07/055893.