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Reflux symptoms in 100 normal infants: diagnostic validity of the infant gastroesophageal reflux questionnaire

S R Orenstein¹, T M Shalaby, J F Cohn

¹Division of Pediatric Gastroenterology, University of Pittsburgh School of Medicine, Pennsylvania, USA.

Clinical Pediatrics

|December 1, 1996

Insights

A validated Infant Gastroesophageal Reflux Questionnaire (I-GERQ) score effectively distinguishes infants with gastroesophageal reflux disease (GERD) from healthy infants, despite common reflux symptoms in normal infants.

Area of Science:

Pediatrics
Gastroenterology
Diagnostic Test Validation

Background:

Gastroesophageal reflux symptoms are common in infants, making differentiation between normal reflux and gastroesophageal reflux disease (GERD) challenging.
The Infant Gastroesophageal Reflux Questionnaire (I-GERQ) is a tool to assess reflux symptoms, but its diagnostic validity for GERD requires further characterization.

Purpose of the Study:

To determine the prevalence of reflux symptoms in normal infants.
To evaluate the diagnostic accuracy of the Infant Gastroesophageal Reflux Questionnaire (I-GERQ) in distinguishing GERD infants from normal infants.
To identify potential caretaking practices that may provoke GERD symptoms.

Main Methods:

Administered a 138-item Infant Gastroesophageal Reflux Questionnaire (I-GERQ) to 100 normal infants and 35 infants diagnosed with GERD.
Analyzed symptom prevalence and differences using Chi-square tests and calculated odds ratios.
Assessed the diagnostic validity of an 11-item, 25-point I-GERQ score by determining its sensitivity, specificity, and predictive values.

Main Results:

Normal infants exhibit a high prevalence of reflux symptoms like daily regurgitation (40%) and hiccups (36%).
Several symptoms were significantly more prevalent in GERD infants compared to normal infants (P < .05), with odds ratios >3 for nearly 20 items.
The 25-point I-GERQ score demonstrated high diagnostic validity with positive predictive values of 1.00 and negative predictive values of 0.94-0.98.

Conclusions:

Despite frequent reflux symptoms in healthy infants, the I-GERQ provides a valid diagnostic score for GERD.
The 25-point I-GERQ score is a reliable tool for differentiating GERD infants from normal infants.
Environmental smoke exposure was not found to be a significant provocative factor for GERD in this study.

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Abstract:

To identify the prevalence of reflux symptoms in normal infants, to characterize the diagnostic validity of a previously described 138-item Infant Gastroesophageal Reflux Questionnaire (I-GERQ) for separating normal infants from those with gastroesophageal reflux disease (GERD), and to identify potentially provocative caretaking practices, we administered the questionnaire to 100 infants attending a well-baby clinic (normals) and to 35 infants referred to the Gastroenterology Division for evaluation for GERI) and testing positive on esophageal pH probe or biopsy (GERD infants). Differences were analyzed by Chi-square, and odds ratios were defined. The diagnostic validity of a 25-point I-GERQ GERD score based on 11 items on the questionnaire was evaluated by calculating its sensitivity, specificity, and positive and negative predictive values. We found that normal infants had a high prevalence of reflux symptoms, such as daily regurgitation (40%), respiratory symptoms, crying more than an hour a day (17%), arching (10%), or daily hiccups (36%) but that many symptoms were significantly more prevalent in the GERD than in the normal infants (Chi-square P < .05), and odds ratios were above 3 for nearly 20 items. The positive and negative predictive values for the 25-point I-GERQ score were 1.00 and .94-.98, respectively. Environmental smoke exposure did not quite reach significance as a provocative factor for GERD. Although normal infants have a high prevalence of symptoms suggesting GERD, a simple questionnaire-based score is a valid diagnostic test with high positive and negative predictive values.

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