They were also contacted weekly by field workers to check on the health status of the child. Any child with a history of blood in stools (any quantity including streaking), or continuous vomiting ( > = 3 episodes in an hour) or any abdominal distension or abdominal lump was considered a case of suspected intussusception and was reviewed by a pediatrician
Selleckchem 5-FU in the study team or at the CMC hospital. The criteria for screening were agreed on by an expert group of pediatricians prior to development of the clinical trial protocol and were designed to be broad and sensitive, such that risk was minimized by ensuring that study investigators intensively followed up and arranged appropriate management for each child suspected to have intussusception. A screening ultrasonagram was performed by a trained sonologist on participants who had symptoms or signs confirmed on review by the study pediatrician. Those identified to have an intussusception, including transient intussusception, were reviewed by a pediatric surgeon and managed according to standard treatment algorithms and classified according to the Brighton criteria [16] by an off-site adjudication committee. Clinical data from hospital records of trial participants was abstracted by a pediatric surgeon and compared to data maintained at the clinical trial site by a second investigator. Data were entered in Microsoft Excel and analyzed using Stata 11 (StataCorp, 2009).
Venetoclax The incidence rate of symptomatic intussusception and those that were Brighton level 1 were calculated from the event rate in this cohort. Incidence rates and 95% CI were calculated assuming a Poisson distribution. Apart from the 16 intussusceptions identified in the vaccine
trial and described separately below, 61 children under two years of age had a diagnosis of intussusception made at CMC between January 2010 and August 2013. Thirty-one (50.8%) were referred not from another hospital while 30 (49.2%) presented directly at CMC. The median time from onset of symptoms to arrival at the hospital was 48 h (range 6–240 h). The median age at presentation was 214 days (IQR 153–321) with 52 events (85.3%) occurring in the first year of life. As shown in Fig. 1, the age distribution was unimodal with a peak between 4 and 6 months of age. Males (42, 65.8%) were twice as likely to present with intussusception as females in this setting. In all 61 intussusceptions evidence of intestinal invagination was present on ultrasonogram. The admission notes of two children were not traced in the records. The presenting symptoms for 59 of the 61 patients whose records were complete is presented in Table 1. Evidence of intestinal obstruction was noted in 27 cases (45.8%). Evidence of intestinal vascular compromise assessed by the passage of blood in stools or red currant jelly stools was present in 55 patients (93.2%). Based on the Brighton Collaboration Intussusception Working Group criteria [16], 59 (96.