A randomized, single-blind, noninferiority trial was conducted among 647 children 6 to 60 months of age with gastroenteritis with mild or no signs of dehydration between the months of October and April during the years 2010 to 2015 in Toronto, Canada. Children with less than 96 hours of symptoms with three or more episodes of vomiting or diarrhea within the preceding 24 hours were randomly assigned to receive half-strength apple juice/preferred fluids or color-matched electrolyte maintenance solution (pediatric electrolyte). Parents were given 2 L of fluid for use in the emergency department and at home, and instructed to give 5 mL aliquots every two to five minutes, replacing 2 mL/kg per vomiting episode and 10 mL/kg per diarrheal episode. Children who vomited received oral ondansetron.
Treatment failure was defined as hospitalization, intravenous rehydration, unscheduled physician visits for the same illness, protracted symptoms for more than seven days, physician request to change therapy, or 3% or greater weight loss at follow-up.
Among 647 randomized children (mean age, 28.3 [SD, 15.9] months) with 331 boys, and 441 without clinical signs of dehydration, 323 were randomized to apple juice and 324 to electrolyte maintenance solution. Baseline characteristics were similar. At least one follow-up was obtained in 99.5% of participants.
In the intent-to-treat analysis, the failure rate was 16.7% (54/323, 95% CI, 12.8-21.2%) for apple juice, and 25% (81/324, 95% CI, 20.4-30.1%) for electrolyte maintenance solution. This was statistically significant, with P < 0.001 for inferiority and P = 0.006 for superiority. Intravenous rehydration at the index visit was required less frequently for children receiving apple juice compared to electrolyte maintenance solution (0.9% [3/323] vs. 6.8% [22/324]; difference -5.9%; 95% CI, -10.5% to -2.0%; P < 0.001). Post hoc analysis revealed a lower overall seven-day intravenous rehydration rate among children receiving apple juice compared with electrolyte maintenance solution (2.5% [8/323] vs. 9.0% [29/324]; difference, -6.5%; 99% CI, -11.6 to -1.8%). Rates of diarrhea, vomiting, and hospitalizations were not significantly different between the groups. No episodes of significant hyponatremia were found.
Acute gastroenteritis remains the second cause of childhood deaths worldwide. Improved fluid management has resulted in lower mortality rates globally, and universal vaccination with rotavirus vaccines in developed countries has significantly mitigated the impact of rotavirus disease. During an episode of acute gastroenteritis, ondansetron reduces the incidence of vomiting and is well established as an adjunct for managing acute gastroenteritis in developed countries.
Mild dehydration in children is difficult to detect clinically. The best parameter to gauge dehydration is comparing accurate weights immediately before the illness and at presentation, though this data is not often available. Loss of 3-5% of body weight is generally required before showing even mild signs of dehydration, and physical findings of dehydration may be subtle or even normal with 7-10% dehydration. The findings of the current study apply to children with no or minimal dehydration, which applies to the majority of children with acute gastroenteritis.
Oral rehydration is the mainstay of fluid management for acute gastroenteritis except for those children with signs of shock or who are unable to tolerate oral fluids because of severe vomiting. Low-osmolality oral rehydration solutions are preferred and the global standard of care. Other fluids, such as decarbonated soda beverages, fruit juices, and tea, are not considered suitable for rehydration primarily because of their high osmolalities and low sodium concentrations. There has been concern about using these solutions because of possible risk of osmotic diarrhea, and water intoxication with hyponatremia.
The results of this study challenge this dogma for managing children with acute gastroenteritis (less than 96 hours of symptoms) with minimal (< 5%) or no dehydration. Another study from Brazil also challenges the concern about the clinical significance of the high osmolality of alternative solutions, showing minimal impact among children even with severe diarrhea.
In high-income countries, the use of half-strength apple juice and fluids preferred by the child may be an appropriate alternative to electrolyte maintenance solution for children with mild acute gastroenteritis and no or minimal physical signs of dehydration.