Randomised feasibility trial of a virtual intervention to address infant car seat misuse.

BACKGROUND: Serious car seat installation errors occur at high rates in infants and children. These errors significantly increase the risk of child injury in a motor vehicle crash, and few interventions have addressed the challenge longitudinally. METHODS: This was a pilot randomised controlled feasibility trial of virtual car seat safety checks for caregivers of newborns recruited from an urban newborn nursery. The control (enhanced usual care (EUC)) group received an in-person car seat check as a newborn and virtual check at 9 months. The intervention group received two additional virtual checks at 3 and 6 months. Installation and infant positioning errors were documented and corrected by a child passenger safety technician (CPST). We measured feasibility and acceptability by tracking caregiver and CPST challenges, and caregiver retention. Group differences were tested for statistical significance using χ2 or Fisher's exact test for categorical variables, and two sample t-tests for continuous variables. RESULTS: 33 caregivers were randomised to the EUC and 28 to the intervention group. Virtual checks were feasible, with variable participation levels at each quarter. Wi-Fi and app challenges noted in 30%. There was satisfaction with the virtual car seat checks. At baseline, car seat installation and infant positioning errors occurred at equal frequency, and at 9 months the intervention group had a significantly lower mean proportion than the EUC group in all categories of errors. In summary, virtual seat checks are feasible and the optimal timing of repeat checks requires additional study. A larger study is needed to further evaluate the effect of longitudinal virtual checks on errors.

Differential activation of neuroinflammatory pathways in children with seizures: A cross-sectional study.

PURPOSE: Inflammation plays a crucial role in epileptogenesis. We analyzed inflammatory cytokines in plasma and saliva from children with seizures and healthy controls and measured their associations with HHV6 and EBV infection. METHODS: We analyzed plasma from 36 children within 24 h of seizures (cases) and 43 healthy controls and saliva from 44 cases and 44 controls with a multiplex immunoassay. Saliva from all controls and 65 cases and blood from 26 controls and 35 cases were also analyzed by PCR for viral DNA. Primary outcome was cytokine levels in cases vs. controls. Secondary outcomes included detection of HHV-6 and EBV viral DNA in cases vs. controls and viral loads in cases vs. controls. Statistical analysis included the Wilcoxon Rank Sum test, Fisher's exact test, ANOVA, and Spearman correlation. RESULTS: Compared to controls, patients had higher levels of CCL11 (p = 0.0018), CCL26 (p<0.001), IL10 (p = 0.044), IL6 (p<0.001), IL8 (p = 0.018), and MIP1ß (p = 0.0012). CCL11 was higher with 3 or more seizures (p = 0.01), seizures longer than 10 min (p = 0.001), and when EEG showed focal slowing (p = 0.02). In saliva, febrile seizures had higher levels of IL-1ß (n = 7, p = 0.04) and new onset seizures had higher IL-6 (n = 15, p = 0.02). Plasma and saliva cytokine levels did not show a correlation. The frequency of HHV-6 and EBV detection was similar across groups and not different than controls. We found no correlation between viral load and cytokine levels. CONCLUSIONS: We showed differential activation of neuroinflammatory pathways in plasma from different seizure etiologies compared to controls, unrelated to viral infection.

The Benefits and Challenges of Preconsent in a Multisite, Pediatric Sickle Cell Intervention Trial.

Enrollment of patients in sickle cell intervention trials has been challenging due to difficulty in obtaining consent from a legal guardian and lack of collaboration between emergency medicine and hematology. We utilized education and preconsent in a pediatric multisite sickle cell intervention trial to overcome these challenges. Overall, 48 patients were enrolled after being preconsented. Variable Institutional Review Board policies related to preconsent validity and its allowable duration decreased the advantages of preconsent at some sites. The utility of preconsent for future intervention trials largely depends on local Institutional Review Board policies. Preeducation may also benefit the consent process, regardless of site differences.