Key Results: The study enrolled 647 children with a mean age of 28 months. The primary outcome was less treatment failure with half-strength apple juice/preferred fluids versus electrolyte maintenance solution.

• 16.7 percent (95 percent CI, 12.8–21.2) versus 25.0 percent (95 percent CI, 20.4–30.1)
• Difference between groups -8.3 percent (97.5 percent CI, –infinity to -2.0) showing non-inferiority (P<0.001)
• Number needed to treat (NNT) of 12 with half-strength apple juice/preferred fluids to prevent one treatment failure

Secondary outcomes included less IV rehydration in the half-strength apple juice/preferred fluids versus electrolyte solution at index ED visit. No statistical differences were seen in the other secondary outcomes.

• IV rehydration at index ED visit 0.9 percent (95 percent CI, 0.2–2.7) versus 6.8 percent (95 percent CI, 4.3–10.1) (P=0.001)

EBM Commentary

• This was a convenience sample of patients presenting 12 hours per day, six days per week to a single-center tertiary care pediatric hospital. Therefore, the sample of patients included in the study may not be reflective of, or cannot be generalized to, the overall population presenting to the emergency department or other practice locations.
• This study was conduced in Toronto, Ontario, Canada, a high-income country. The results shouldn’t be extrapolated to low- and middle-income countries because children in those countries are at a higher risk of gastroenteritis-related complications. Also, the etiology of gastroenteritis can vary in different geographical locations, limiting the generalizability of this study to those children.
• The primary outcome of treatment failure was a composite of a number of different measures that may not all have the same clinical relevance to the caregiver and patient. In this composite outcome, the most statistically significant difference was seen in IV rehydration rates.
• Allocation was concealed in the emergency department but not at home. Documentation informed parents which treatment group their child was allocated to, eliminating blinding. This has the potential to introduce bias into the study. It’s hard to know in which direction, if any, the bias would deviate the results.
• This was designed as a non-inferiority study. However, the difference observed was greater than their prespecified non-inferiority margin of 7.5 percent. Thus, they actually demonstrated that dilute apple juice/preferred fluids was superior to the electrolyte maintenance solution.

Bottom Line: In children from high-income countries presenting with mild gastroenteritis and minimal dehydration, oral rehydration with dilute apple juice followed by preferred fluids appears to be a reasonable alternative to electrolyte maintenance solutions.

Case Resolution: The boy is offered half-strength apple juice and tolerates it well in the emergency department. After a short period of observation, he’s discharged home with his caregivers. They are advised to continue his usual dietary patterns, including his preferred fluids to replace losses, and are given detailed instructions on when to return to the emergency department.