BACKGROUND Acute gastroenteritis develops in millions of children in the United States every year, and treatment with probiotics is common. However, data to support the use of probiotics in this population are limited. METHODS We conducted a prospective, randomized, double-blind trial involving children 3 months to 4 years of age with acute gastroenteritis who presented to one of 10 U.S. pediatric emergency departments. Participants received a 5-day course of Lactobacillus rhamnosus GG at a dose of 1×1010 colony-forming units twice daily or matching placebo. Follow-up surveys were conducted daily for 5 days and again 14 days after enrollment and 1 month after enrollment. The primary outcome was moderate-to-severe gastroenteritis, which was defined as an illness episode with a total score on the modified Vesikari scale of 9 or higher (scores range from 0 to 20, with higher scores indicating more severe disease), within 14 days after enrollment. Secondary outcomes included the duration and frequency of diarrhea and vomiting, the duration of day-care absenteeism, and the rate of household transmission (defined as the development of symptoms of gastroenteritis in previously asymptomatic household contacts). RESULTS Among the 971 participants, 943 (97.1%) completed the trial. The median age was 1.4 years (interquartile range, 0.9 to 2.3), and 513 participants (52.9%) were male. The modified Vesikari scale score for the 14-day period after enrollment was 9 or higher in 55 of 468 participants (11.8%) in the L. rhamnosus GG group and in 60 of 475 participants (12.6%) in the placebo group (relative risk, 0.96; 95% confidence interval, 0.68 to 1.35; P = 0.83). There were no significant differences between the L. rhamnosus GG group and the placebo group in the duration of diarrhea (median, 49.7 hours in the L. rhamnosus GG group and 50.9 hours in the placebo group; P = 0.26), duration of vomiting (median, 0 hours in both groups; P = 0.17), or day-care absenteeism (median, 2 days in both groups; P = 0.67) or in the rate of household transmission (10.6% and 14.1% in the two groups, respectively; P = 0.16). CONCLUSIONS Among preschool children with acute gastroenteritis, those who received a 5-day course of L. rhamnosus GG did not have better outcomes than those who received placebo. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; ClinicalTrials.gov number, NCT01773967.)

Objective The burden of acute gastroenteritis (AGE) in U.S. children is substantial. Research into outpatient treatment strategies has been hampered by the lack of easily used and validated gastroenteritis severity scales relevant to the populations studied. We sought to evaluate, in a U.S. cohort, the reliability, construct validity and generalizability of a gastroenteritis severity scale previously derived in a Canadian population, the Modified Vesikari Score (MVS). Methods We conducted a prospective, cohort, clinical observational study of children 3-48 months of age with AGE presenting to 5 U.S. emergency departments (EDs). A baseline MVS score was determined in the ED, and telephone follow-up 14 days after presentation was used to assign the follow-up MVS. We determined reliability using inter-item correlations; construct validity via principal component factor analysis; cross sectional construct validity via correlations with the presence of dehydration, hospitalization and day-care and parental work absenteeism, and generalizability via score distribution among sites. Results 218/274 patients (80%) were successfully contacted for follow-up. Cronbach's alpha was 0.63 indicating expectedly low internal reliability, because of the multidimensional properties of the MVS. Factor analysis supported the appropriateness of retaining all variables in the score. Disease severity correlated with dehydration (P<0.001), hospitalization (P<0.001), and subsequent day care (P=0.01) and work (P<0.001) absenteeism. The MVS was normally distributed, and scores did not differ between sites. Conclusion The MVS effectively measures global severity of disease and performs similarly in varying populations within the U.S. health care system. Its characteristics support its use in multi-site outpatient clinical trials.

BackgroundThe paradigm is shifting from separating family members from their children during resuscitation to one of patient-and family-centered care. However, widespread acceptance is still lacking. Objective To measure attitudes, behaviors, and experiences of family members of pediatric patients during the resuscitation phase of trauma care, including family members who were present and those who were not. Methods An observational mixed-methods study using structured interviews and focus groups was conducted at 3 level 1 pediatric trauma centers. Family members of children who met trauma team activation criteria (N = 126; 99 present, 27 not present) were interviewed; 25 also participated in focus groups. Results Mean attitude scores indicated a positive attitude about being present during the resuscitation phase of trauma care (3.65; SD, 0.37) or wanting to be present (3.2; SD, 0.60). Families present reported providing emotional support (94%) for their child and health care information (92%) to the medical team. Being present allowed them to advocate for their child, understand their child's condition, and provide comfort. Families in both groups felt strongly that the choice was their right but was contingent upon their bedside behavior. Conclusions Study findings demonstrated compelling family benefits for presence during pediatric trauma care. This study is one of the first to report on family members who were not present. The practice of family presence should be made a priority at pediatric trauma centers.

Upon activation, platelets release a powerful cocktail of soluble and vesicular signals, collectively termed the "platelet releasate" (PR). Although several studies have used qualitative/quantitative proteomic approaches to characterize PR; with debated content and significant inter-individual variability reported, confident, and reliable insights have been hindered. Using label-free quantitative (LFQ)-proteomics analysis, a reproducible, quantifiable investigation of the 1U mL thrombin-induced PR from 32 healthy adults was conducted. MS proteomics data are available via ProteomeXchange, identifier PXD009310. Of the 894 proteins identified, 277 proteins were quantified across all donors and form a "core" PR. Bioinformatics and further LFQ-proteomic analysis revealed that the majority (84%) of "core" PR proteins overlapped with the protein composition of human platelet-derived exosomes. Vesicles in the exosomal-size range were confirmed in healthy-human PR and reduced numbers of similar-sized vesicles were observed in the PR of a mouse model of gray platelet syndrome, known to be deficient in platelet alpha-granules. Lastly, the variability of proteins in the PR was assessed, and reproducible secretion levels were found across all 32 healthy donors. Taken together, the PR contains valuable soluble and vesicular cargo and has low-population variance among healthy adults, rendering it a potentially useful platform for diagnostic fingerprinting of platelet-related disease.