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Kingsbury D.J.,Randall Childrens Hospital at Legacy Emanuel | Bader-Meunier B.,Hopital Necker Enfants Malades | Patel G.,AbbVie | Arora V.,AbbVie | And 2 more authors.
Clinical Rheumatology | Year: 2014

The objective of this study was to assess the safety of adalimumab in patients aged 2 to <4 years old or ≥4 years old weighing <15 kg with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA). Clinical effectiveness and pharmacokinetics (PK) of adalimumab were also evaluated. This was an international, multicenter, open-label, phase 3b study in 32 patients with active JIA that were treated with adalimumab 24 mg/m2 (maximum = 20 mg/dose) every other week up to 120 weeks, with or without concomitant methotrexate. Adverse events (AEs) were summarized for completed visits. Efficacy endpoints included American College of Rheumatology pediatric (PedACR) 30/50/70/90 responses and JIA core components. Adalimumab serum trough concentrations were measured in a subset of patients. Among the patients, 88 % were female. Baseline mean age, weight, and JIA duration were 3 years, 13 kg, and 12 months, respectively; 39 % had elevated C-reactive protein. AE incidence rates included any AEs (29/32, 91 %), serious AEs (5/32, 16 %), infectious AEs (25/32, 78 %), and serious infections (3/32, 9 %). No deaths, malignancies, or opportunistic infections were reported. Growth was not adversely impacted. At week 96, 92 % of patients achieved PedACR30, and 77 % achieved PedACR70. Improvements in JIA core components were observed. Mean steady-state serum adalimumab trough concentrations were 7-8 μg/mL at weeks 12 and 24. Adalimumab was well tolerated in JIA patients aged 2 to <4 years old or ≥4 years old weighing <15 kg. The efficacy and PK of adalimumab were comparable to those seen in older JIA patients. © 2014 The Author(s). Source


Bath S.,University of Portland | Lines J.,Randall Childrens Hospital at Legacy Emanuel | Loeffler A.M.,Randall Childrens Hospital at Legacy Emanuel | Malhotra A.,University of the Pacific at Stockton | Turner R.B.,University of Portland
Journal of Thoracic and Cardiovascular Surgery | Year: 2016

Objectives: The optimal duration of antimicrobial prophylaxis following pediatric cardiac surgery is still debated. Adult studies suggest that shorter durations are adequate, but there is a paucity of data on pediatric patients. Methods: This quasi-experimental study reviewed the charts of patients 18 years and younger who underwent cardiac surgery from April 2011 to November 2014 at a single institution. Starting in April 2013, a protocol was implemented to limit antimicrobial prophylaxis to 48 hours following sternal closure. Two analyses were performed: (1) identification of risk factors for surgical site infections from the entire cohort, and (2) comparison of surgical site infection incidence in the pre- and postprotocol groups. Results: In the entire cohort, delayed sternal closure (adjusted odds ratio [OR], 5.7; 95% confidence interval [CI], 1.8-17.9) and younger age (adjusted OR, 2.1; 95% CI, 1.1-3.8) were associated with incidence of surgical site infection. Following the protocol change, duration of antimicrobial prophylaxis decreased from 4.2 ± 2.7 to 1.9 ± 1.3 days (P < .0001). After adjusting for age and delayed sternal closure, the postprotocol group had an adjusted OR of 0.98 (95% CI, 0.32-3.00) for occurrence of surgical site infection. Other outcomes were not altered following the protocol change. Conclusions: Restricting antimicrobial prophylaxis to 48 hours following pediatric cardiac surgery did not increase the incidence of surgical site infection at our institution. Further study is needed to validate this finding and to identify practices that reduce surgical site infections in those with delayed sternal closure. © 2016 The American Association for Thoracic Surgery. Source


Henderson L.A.,Harvard University | Zurakowski D.,Harvard University | Angeles-Han S.T.,Emory University | Lasky A.,Randall Childrens Hospital at Legacy Emanuel | Lo M.S.,Harvard University
Pediatric Rheumatology | Year: 2016

Background: There is not yet a commonly accepted, standardized approach in the treatment of juvenile idiopathic uveitis when initial steroid therapy is insufficient. We sought to assess current practice patterns within a large cohort of children with juvenile uveitis. Methods: This is a cross-sectional cohort study of patients with uveitis enrolled in the Childhood Arthritis and Rheumatology Research Alliance (CARRAnet) registry. Clinical information including, demographic information, presenting features, disease complications, and medications were collected. Chi-square and Fisher's exact tests were used to assess for associations between medications and clinical characteristics. Results: Ninety-two children with idiopathic and 656 with juvenile idiopathic arthritis (JIA)-associated uveitis were identified. Indication (arthritis or uveitis) for medication use was not available for JIA patients; therefore, detailed analysis was limited to children with idiopathic uveitis. In this group, 94 % had received systemic steroids. Methotrexate (MTX) was used in 76 % of patients, with oral and subcutaneous forms given at similar rates. In multivariable analysis, non-Caucasians were more likely to be treated initially with subcutaneous MTX (P = 0.003). Of the 53 % of patients treated with a biologic DMARD, all received a tumor necrosis factor (TNF) inhibitor. TNF inhibitor use was associated with a higher frequency of cataracts (52 % vs 21 %; P = 0.001) and antinuclear antibody positivity (49 % vs 29 %; P = 0.04), although overall complication rates were not higher in these patients. Conclusion: Among idiopathic uveitis patients enrolled in the CARRAnet registry, MTX was the most commonly used DMARD, with subcutaneous and oral forms equally favored. Patients who received a TNF inhibitor were more likely to be ANA positive and have cataracts. © 2016 Henderson et al. Source


Huston R.K.,Randall Childrens Hospital at Legacy Emanuel | Markell A.M.,Randall Childrens Hospital at Legacy Emanuel | McCulley E.A.,Randall Childrens Hospital at Legacy Emanuel | Pathak M.,Devers Eye Institute | And 4 more authors.
Infant, Child, and Adolescent Nutrition | Year: 2014

Objective: The purpose of this study is to report our experience with an exclusive human milk-based diet (EHM) versus diets of mother's milk supplemented with banked human milk (DHM) or formula (PTF) plus bovine fortifier. Second, we evaluated the cost-effectiveness of using EHM. Design/Methods: This is a retrospective study of infants ≤1500 g birth weight (VLBW) admitted to the NICU from January 1, 2007, to December 31, 2011. Primary outcomes were rates of Bell stage 2 to 3 necrotizing enterocolitis (NEC) and NEC plus significant gastrointestinal bleeding (GIB). There were 3 groups for analysis according to diet: PTF, DHM, and EHM. Binary outcomes were analyzed using a multivariate logistic regression. Linear analysis of covariance was used to analyze continuous outcomes. Cost analysis used costs from a previous study for stage 2 and 3 NEC and from a matched control analysis for infants in our study for stage 1 NEC. Results: Infants who received EHM (n = 44) had higher rates of risk factors for NEC compared with DHM (n = 224) and PTF (n = 93). Rates of NEC were decreased for EHM versus PTF (odds ratio [OR] = 0.060; confidence interval [CI] = 0.003-0.445; P = .019) and NEC plus GIB were decreased for EHM versus DHM (OR = 0.070; CI = 0.004-0.369; P = .012) and EHM versus PTF (OR = 0.062; CI = 0.003-0.366; P = .011). A cost saving was shown when using EHM for VLBW infants with several risk factors for NEC but not all VLBW infants. Conclusions: EHM lowered the incidence of NEC compared with PTF and NEC plus GIB compared with DHM and PTF. Using EHM in VLBW infants at higher risk of NEC appears to be cost-effective. © 2014 The Author(s). Source


Huston R.K.,Randall Childrens Hospital at Legacy Emanuel | Markell A.M.,Randall Childrens Hospital at Legacy Emanuel | McCulley E.A.,Randall Childrens Hospital at Legacy Emanuel | Marcus M.J.,Northwest Newborn Specialists | Cohen H.S.,Northwest Newborn Specialists
Nutrition in Clinical Practice | Year: 2013

Background: Computerized software programs reduce errors and increase consistency when ordering parenteral nutrition (PN). The purpose of this study was to evaluate the effectiveness of our computerized neonatal PN calculator ordering program in reducing errors and optimizing nutrient intake. Materials and Methods: This was a retrospective study of infants requiring PN during the first 2-3 weeks of life. Caloric, protein, calcium, and phosphorus intakes; days above and below amino acid (AA) goals; and PN ordering errors were recorded. Infants were divided into 3 groups by birth weight for analysis: ≤1000 g, 1001-1500 g, and >1500 g. Intakes and outcomes of infants before (2007) vs after (2009) implementation of the calculator for each group were compared. Results: There were no differences in caloric, protein, or phosphorus intakes in 2007 vs 2009 in any group. Mean protein intakes were 97%-99% of goal for ≤1000-g and 1001- to 1500-g infants in 2009 vs 87% of goal for each group in 2007. In 2007, 7.6 per 100 orders were above and 11.5 per 100 were below recommended AA intakes. Calcium intakes were higher in 2009 vs 2007 in ≤1000-g (46.6 ± 6.1 vs 39.5 ± 8.0 mg/kg/d, P <.001) and >1500-g infants (50.6 ± 7.4 vs 39.9 ± 8.3 mg/kg/d, P <.001). Ordering errors were reduced from 4.6 per 100 in 2007 to 0.1 per 100 in 2009. Conclusion: Our study reaffirms that computerized ordering systems can increase the quality and safety of neonatal PN orders. Calcium and AA intakes were optimized and ordering errors were minimized using the computer-based ordering program. © 2013 American Society for Parenteral and Enteral Nutrition. Source

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