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Original Investigation |

Effect of Dilute Apple Juice and Preferred Fluids vs Electrolyte Maintenance Solution on Treatment Failure Among Children With Mild Gastroenteritis A Randomized Clinical Trial

Stephen B. Freedman, MDCM, MSc1; Andrew R. Willan, PhD2; Kathy Boutis, MD3,4; Suzanne Schuh, MD3,4
[+] Author Affiliations
1Sections of Pediatric Emergency Medicine and Gastroenterology, Alberta Children’s Hospital, and Alberta Children’s Hospital Research Institute, University of Calgary, Calgary, Canada
2Ontario Child Health Support Unit, Hospital for Sick Children Research Institute, Dalla Lana School of Public Health, University of Toronto, Faculty of Medicine, Toronto, Ontario, Canada
3Division of Pediatric Emergency Medicine, The Hospital for Sick Children and Child Health Evaluative Sciences, Toronto, Ontario, Canada
4Hospital for Sick Children Research Institute, Department of Pediatrics, University of Toronto, Faculty of Medicine, Toronto, Ontario, Canada
JAMA. 2016;315(18):1966-1974. doi:10.1001/jama.2016.5352.
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Importance  Gastroenteritis is a common pediatric illness. Electrolyte maintenance solution is recommended to treat and prevent dehydration. Its advantage in minimally dehydrated children is unproven.

Objective  To determine if oral hydration with dilute apple juice/preferred fluids is noninferior to electrolyte maintenance solution in children with mild gastroenteritis.

Design, Setting, and Participants  Randomized, single-blind noninferiority trial conducted between the months of October and April during the years 2010 to 2015 in a tertiary care pediatric emergency department in Toronto, Ontario, Canada. Study participants were children aged 6 to 60 months with gastroenteritis and minimal dehydration.

Interventions  Participants were randomly assigned to receive color-matched half-strength apple juice/preferred fluids (n=323) or apple-flavored electrolyte maintenance solution (n=324). Oral rehydration therapy followed institutional protocols. After discharge, the half-strength apple juice/preferred fluids group was administered fluids as desired; the electrolyte maintenance solution group replaced losses with electrolyte maintenance solution.

Main Outcomes and Measures  The primary outcome was a composite of treatment failure defined by any of the following occurring within 7 days of enrollment: intravenous rehydration, hospitalization, subsequent unscheduled physician encounter, protracted symptoms, crossover, and 3% or more weight loss or significant dehydration at in-person follow-up. Secondary outcomes included intravenous rehydration, hospitalization, and frequency of diarrhea and vomiting. The noninferiority margin was defined as a difference between groups of 7.5% for the primary outcome and was assessed with a 1-sided α=.025. If noninferiority was established, a 1-sided test for superiority was conducted.

Results  Among 647 randomized children (mean age, 28.3 months; 331 boys [51.1%]; 441 (68.2%) without evidence of dehydration), 644 (99.5%) completed follow-up. Children who were administered dilute apple juice experienced treatment failure less often than those given electrolyte maintenance solution (16.7% vs 25.0%; difference, −8.3%; 97.5% CI, −∞ to −2.0%; P < .001 for inferiority and P = .006 for superiority). Fewer children administered apple juice/preferred fluids received intravenous rehydration (2.5% vs 9.0%; difference, −6.5%; 99% CI, −11.6% to −1.8%). Hospitalization rates and diarrhea and vomiting frequency were not significantly different between groups.

Conclusions and Relevance  Among children with mild gastroenteritis and minimal dehydration, initial oral hydration with dilute apple juice followed by their preferred fluids, compared with electrolyte maintenance solution, resulted in fewer treatment failures. In many high-income countries, the use of dilute apple juice and preferred fluids as desired may be an appropriate alternative to electrolyte maintenance fluids in children with mild gastroenteritis and minimal dehydration.

Trial Registration  clinicaltrials.gov Identifier: NCT01185054

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Figure 1.
Screening, Randomization, and Follow-up

aSignificant medical history includes all children with known gastrointestinal diseases (ie, inflammatory bowel disease, celiac disease) or any other underlying disease process that might place the child at an increased risk of treatment failure.

bOne child did not receive electrolyte maintenance solution as randomized during the period between randomization and provision of study medications; the family left the emergency department (ED). The family was contacted to enable provision of the supplies but declined to initiate their use at that time.

cThese categories are not mutually exclusive.

dReasons for absent Canadian Institute for Health Information data: 6 cases with enrollment dates after April 1, 2015 (data unavailable until 2016), 13 with invalid health care numbers, and 12 without any data.

eCaregivers were contacted daily to track outcomes (revisits, intravenous fluid administration, and hospitalization). Calls were be made by a research nurse using a standardized set of questions and responses to caregiver queries.

fAll participants were provided a diary in which to record follow-up health care clinician visits, diarrhea, vomiting, child care, expenses, and fluids administered. These were returned at the final in-person reassessment or by mail.

gTo promote the collection of outcome data, a letter was sent by registered mail to all families not contacted by telephone after 7 days requesting that they either contact the research nurse by telephone or complete and return a data form focused on the outcome measures.

hPrimary analysis using ED outcome data refers to the analysis conducted including all study participants who had ED outcome data available. Primary analysis refers to the analysis performed including only participants who had follow-up data collected.

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Figure 2.
Treatment Failure Comparing Half-Strength Apple Juice/Preferred Fluids Therapy and Electrolyte Maintenance Solution Groups as a Function of Age

The threshold odds ratio of 1.44 for noninferiority is based on the actual failure rate (25%) in the electrolyte maintenance solution group in our study using the a priori–determined margin of noninferiority (7.5%), yielding the threshold failure rate of 32.5% for the half-strength apple juice/preferred fluids group. The observed odds ratio was 0.60 (ignoring age). A nonlinear relationship was identified among age, treatment failure, and treatment group (ie, half-strength apple juice/preferred fluids or electrolyte maintenance solution). The best model contained a term for group, age, the natural log of age, and the interactions between group and age and group and the natural log of age. The model on which this figure is based is specified in eAppendix 5 in Supplement 1 and was generated from the estimated parameters (log odds ratios and corresponding variances and covariances) from the logistic regression model.

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