Gastroesophageal reflux (GER) is a common physiological occurrence in infants and young children, characterized by the retrograde movement of gastric contents into the esophagus, frequently resulting in regurgitation or vomiting. It is a normal postprandial phenomenon in infancy and typically resolves spontaneously by 12 to 24 months of age due to maturation of the lower esophageal sphincter (LES) and postural development (1,2).

However, when GER leads to troublesome symptoms such as feeding refusal, poor weight gain, persistent irritability, or recurrent respiratory issues, it is classified as gastroesophageal reflux disease (GERD). GERD represents the pathological end of the GER spectrum and is the most common esophageal disorder in children (1,3). If left undiagnosed or untreated, GERD can result in complications such as esophagitis, recurrent lower respiratory tract infections (LRTIs), feeding aversion, and rarely, Barrett's esophagus (2,4).

The clinical diagnosis of GERD in children poses significant challenges due to the nonspecific nature of symptoms and overlap with other pediatric disorders. Although objective diagnostic modalities such as 24-hour pH monitoring and multichannel intraluminal impedance are considered gold standards, they are invasive, costly, and not easily accessible in routine pediatric settings, especially in resource-limited environments (3,4).

To overcome these limitations, non-invasive clinical tools like the Infant Gastroesophageal Reflux Questionnaire-Revised (IGERQ-R) have been developed. This parent-reported questionnaire is designed to evaluate the frequency and severity of GERD-related symptoms, offering a validated approach to aid diagnosis without invasive procedures (5).

Furthermore, epidemiological data suggest that GERD may be more prevalent in children with certain risk factors and is increasingly being recognized in primary care settings (6).

In this context, the present study was undertaken to determine the prevalence of GERD among regurgitant infants and children aged 6 months to 10 years in a tertiary care setting using milk scan scintigraphy and to evaluate the diagnostic utility of the IGERQ score in clinical practice.

Study Design and Setting

This was a hospital-based, cross-sectional observational study conducted in the Department of Paediatrics at Niloufer Hospital, Hyderabad — a tertiary care referral center for pediatric illnesses.

Study Period

The study was carried out over a period of 18 months, from June 2020 to December 2021.

Study Population

Children aged between 6 months and 120 months (10 years) presenting with symptoms of regurgitation to the outpatient and inpatient departments of the hospital were considered for inclusion.

Sample Size

A total of 82 children were enrolled in the study based on convenience sampling and inclusion criteria.

Inclusion Criteria

Children aged 6 months to 120 months.

Both genders.

Children presenting with vomiting/regurgitation ≥2 times per day for more than 3 weeks.

Parental/guardian consent for participation in the study.

Exclusion Criteria

Acutely ill children.

Children with known bronchial asthma, neurological disorders, or history of gastrointestinal surgery.

Children already receiving treatment for GERD.

Children and/or guardians unwilling to participate.

Study Procedure

Eligible children were recruited after obtaining informed consent from parents or guardians. A detailed history was taken and physical examination was performed. Each subject's GERD symptom burden was assessed using the Infant Gastroesophageal Reflux Questionnaire (IGERQ). Subsequently, all participants underwent a milk scan scintigraphy using technetium-99m sulfur colloid to objectively assess gastroesophageal reflux.

Milk Scan Protocol

Children were fasted for at least 3 hours prior to the test. A nasogastric tube was used to administer Tc-99m sulfur colloid mixed with milk. Dynamic scintigraphic images were obtained with the patient in a supine position using PHILIPS or SIEMENS gamma cameras. Images were analyzed for the presence, frequency, and extent of reflux episodes.

Statistical Analysis

Data were entered and analyzed using Microsoft Excel 2010 and Epi Info version 7.2.0. Descriptive statistics were used for demographic and clinical characteristics. Continuous variables were expressed as mean ± SD, and categorical variables as frequencies and percentages.

The Chi-square test was used to assess associations between GERD and clinical features. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and diagnostic accuracy of the IGERQ score were calculated using milk scan results as the reference standard. A p-value < 0.05 was considered statistically significant.

A total of 82 children aged between 6 months and 10 years presenting with symptoms of regurgitation were included in the study. The majority of the study population were infants (≤1 year), comprising 58.5%, followed by children aged 2 years (26.8%). The least representation was among children aged 5 years and above (4.9%). The gender distribution was nearly equal, with 51.2% males and 48.8% females (Table 1).

Table 1: Demographic Profile of Study Participants

Clinical Profile

Among the enrolled children, the most commonly observed symptoms were refusal to feed (21.95%) and poor weight gain (19.51%). Other clinical features included recurrent lower respiratory tract infections (7.31%), pallor (7.31%), irritability (4.87%), and stridor (4.87%) (Table 2).

Table 2: Clinical Features Observed in the Study Population

Prevalence of GERD

The prevalence of gastroesophageal reflux disease (GERD), as assessed by milk scan scintigraphy, was found to be 37.8% (31 out of 82 children), while the remaining 62.2% tested negative (Table 3).

Table 3: Prevalence of GERD Based on Milk Scan Results

Association of Clinical Features with GERD

A statistically significant association was noted between GERD and clinical features such as poor weight gain (p = 0.02), refusal to feed (p = 0.004), and recurrent pneumonia (p = 0.01). However, features such as irritability (p = 0.60), stridor (p = 0.60), and pallor (p = 0.52) did not show significant association with GERD (Table 4).

Table 4: Association of Clinical Features with GERD

Diagnostic Accuracy of IGERQ Score

Evaluation of the Infant Gastroesophageal Reflux Questionnaire (IGERQ) score revealed high diagnostic accuracy when compared to the milk scan. The sensitivity was 94.12%, specificity 93.55%, positive predictive value 96.00%, and negative predictive value 90.63%, yielding an overall diagnostic accuracy of 93.90% (Table 5).

Table 5: Diagnostic Accuracy of IGERQ Score Compared to Milk Scan

This cross-sectional study was conducted to assess the prevalence of gastroesophageal reflux disease (GERD) among regurgitant children aged 6 to 120 months and to evaluate the diagnostic accuracy of the Infant Gastroesophageal Reflux Questionnaire (IGERQ) score in a tertiary care hospital setting. Additionally, the study explored the association of various clinical features with GERD diagnosed via milk scan scintigraphy.

In our study, the prevalence of GERD was found to be 37.8%, which aligns closely with the findings of Kandaswamy et al., who reported a prevalence of 30.8% using the IGERQ score and upper gastrointestinal endoscopy among regurgitant infants (7). In contrast, Agarwal et al. observed a higher prevalence of 71.4% in children with recurrent and persistent lower respiratory tract infections, possibly due to a more selective high-risk study population and differing diagnostic protocols (8).

The majority of study participants were infants (58.5%), reflecting the peak incidence of physiological GER in the first year of life. A slight male predominance (51.2%) was noted, consistent with earlier studies, including those by Agarwal et al. and Hegar et al., suggesting a potential gender-based predisposition to GERD (8,10).

Significant associations were observed between GERD and clinical symptoms such as refusal to feed (p=0.004), poor weight gain (p=0.02), and recurrent pneumonia (p=0.01). These findings underscore that feeding difficulties and respiratory symptoms are strong clinical indicators of underlying GERD. Similar associations have been reported in literature, highlighting the importance of thorough symptom evaluation in suspected cases (7,12).

The IGERQ score showed excellent diagnostic performance in our study, with a sensitivity of 94.12%, specificity of 93.55%, PPV of 96%, NPV of 90.63%, and overall diagnostic accuracy of 93.9%. These results support findings by Kandaswamy et al., reinforcing the value of IGERQ as a valid, non-invasive screening tool in pediatric GERD diagnosis (7). Given its ease of administration and reliability, the IGERQ score is particularly beneficial in resource-limited settings where access to advanced diagnostics is constrained.

Milk scan scintigraphy was utilized as the reference diagnostic modality in this study. Although not considered the gold standard, several studies have reported its utility in detecting clinically significant reflux, particularly in infants with recurrent vomiting and suspected aspiration, making it a practical diagnostic alternative in pediatric practice (9).

Interestingly, symptoms such as stridor, irritability, and pallor did not show statistically significant associations with GERD, indicating that while these may be present, they are not reliable standalone indicators of the disease. Conservative measures such as feeding modifications and parental reassurance remain the cornerstone of management in uncomplicated cases, as emphasized by Hegar et al. and Orenstein et al. (10,11).

Overall, the findings from this study contribute to the growing body of evidence supporting symptom-based diagnosis of GERD using structured tools such as the IGERQ and highlight the need for clinical vigilance in identifying high-risk pediatric populations.

This cross-sectional study demonstrated that gastroesophageal reflux disease (GERD) is prevalent in 37.8% of regurgitant infants and children aged 6 to 120 months attending a tertiary care center. Clinical features such as refusal to feed, poor weight gain, and recurrent pneumonia showed significant association with GERD, emphasizing the importance of careful clinical evaluation. The Infant Gastroesophageal Reflux Questionnaire (IGERQ) score proved to be a highly sensitive and specific tool, with strong diagnostic accuracy in identifying GERD when compared to milk scan scintigraphy. Given its simplicity and non-invasive nature, the IGERQ score can be effectively utilized as a screening tool to aid early diagnosis and reduce unnecessary investigations.

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