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Randomized Controlled Trial
. 2008 Mar;152(3):310-4.
doi: 10.1016/j.jpeds.2007.09.009. Epub 2007 Nov 7.

Efficacy of conservative therapy as taught in the primary care setting for symptoms suggesting infant gastroesophageal reflux

Affiliations
Randomized Controlled Trial

Efficacy of conservative therapy as taught in the primary care setting for symptoms suggesting infant gastroesophageal reflux

Susan R Orenstein et al. J Pediatr. 2008 Mar.

Abstract

Objective: To determine the efficacy of non-pharmacologic conservative therapy for infant gastroesophageal reflux disease (GERD).

Study design: Consenting parents of the first 50 screened infants who met inclusion/exclusion criteria including abnormal (>16/42) scores on the Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R; n = 40) were taught conservative therapy measures by each site's study nurse: feeding modifications, positioning, and tobacco smoke avoidance. We compared I-GERQ-R scores and symptom response details before and 2 weeks after institution of these measures with 2-tail Wilcoxon signed ranks test in the 37 infants (age range, 4-43 weeks; median age, 13 weeks) who completed the run-in.

Results: The median initial and final scores were 23 (16-36) and 18 (7-34; P < .000001). The median score change was -5 (+6--16). Scores of 78% improved at all; 59% improved at least the threshold of 5 points; 24% became normal. Scores for individual symptoms related to regurgitation, crying, and arching improved significantly.

Conclusions: Two weeks of conservative therapy measures taught in primary care improved 59% beyond the 5-point threshold and normalized 24% of infants with symptom severity diagnostic for GERD, as substantiated with a responsiveness-validated instrument.

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