Blood pressure in children has consistently been related to adult blood pressure, with implications for long-term prevention of cardiovascular disease. The epidemic of obesity in children has resulted in corresponding increases in childhood blood pressure. In this paper, the authors develop norms for childhood blood pressure among normal-weight children (body mass index <85th percentile based on Centers for Disease Control and Prevention guidelines) as a function of age, sex, and height, using data from 49,967 children included in the database of the National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents (the Pediatric Task Force). The authors considered three types of models for pediatric blood pressure data, including polynomial regression, restricted cubic splines, and quantile regression, with the latter providing the best fit. The sex-specific norms presented here are a nonlinear function of both age and height and are generally slightly lower than previously developed norms based on Pediatric Task Force data including both normal-weight and overweight children.
Large differences in blood pressure by ethnic group are apparent among adults. There is uncertainty as to whether similar differences by ethnic group exist among children and if so, the age of onset. Blood pressure (BP) measurements were obtained from 58,698 children at 78,556 visits using data from the Pediatric Task Force data, a collection of 11 studies with BP data from children and adolescents age 1–17. Generalized estimating equation methods were used to identify sex-specific differences in body mass index (BMI)-adjusted rates of BP elevation and pre-hypertension by ethnic group. Significant BMI-adjusted differences in rates of BP elevation were found between Hispanic boys vs. Caucasian boys (OR = 1.21, 95% CI = 1.07–1.37, p=0.002). No overall significant differences were found between African-American (AA) boys vs. Caucasian (Cauc) boys (OR = 1.03, 95% CI = 0.95–1.12, p=0.49); however, there was significant effect modification (p = 0.01) with significant differences found for normal weight boys (BMI < 85th percentile) (ORAA vs. Cauc = 1.14, 95% CI = 1.03 –1.27, p=0.01), but not for overweight boys (BMI ≥ 85th percentile) (ORAA vs. Cauc = 0.90, 95% CI = 0.78–1.05, p=0.20). No overall ethnic group differences in BMI-adjusted rates of hypertension were found for girls. Ethnic differences in prevalence rates of pediatric BP elevation that are not explained by obesity are present, primarily in boys. Whether these differences are due to genetic or environmental factors is unknown.
Although seizures have a higher incidence in neonates than any other age group and are associated with significant mortality and neurodevelopmental disability, treatment is largely guided by physician preference and tradition, due to a lack of data from well-designed clinical trials. There is increasing interest in conducting trials of novel drugs to treat neonatal seizures, but the unique characteristics of this disorder and patient population require special consideration with regard to trial design. The Critical Path Institute formed a global working group of experts and key stakeholders from academia, the pharmaceutical industry, regulatory agencies, neonatal nurse associations, and patient advocacy groups to develop consensus recommendations for design of clinical trials to treat neonatal seizures. The broad expertise and perspectives of this group were invaluable in developing recommendations addressing: (1) use of neonate-specific adaptive trial designs, (2) inclusion/exclusion criteria, (3) stratification and randomization, (4) statistical analysis, (5) safety monitoring, and (6) definitions of important outcomes. The guidelines are based on available literature and expert consensus, pharmacokinetic analyses, ethical considerations, and parental concerns. These recommendations will ultimately facilitate development of a Master Protocol and design of efficient and successful drug trials to improve the treatment and outcome for this highly vulnerable population.
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