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Jayaram N.,Saint Lukes Mid America Heart Institute | Nadkarni V.,Childrens Hospital of Philadelphia | Berg R.A.,Childrens Hospital of Philadelphia | Tang F.,Saint Lukes Mid America Heart Institute | And 2 more authors.
Circulation: Cardiovascular Quality and Outcomes | Year: 2014

Background-Although survival after in-hospital cardiac arrest is likely to vary among hospitals caring for children, validated methods to risk-standardize pediatric survival rates across sites do not currently exist. Methods and Results-From 2006 to 2010, within the American Heart Association's Get With the Guidelines-Resuscitation registry for in-hospital cardiac arrest, we identified 1551 cardiac arrests in children (<18 years). Using multivariable hierarchical logistic regression, we developed and validated a model to predict survival to hospital discharge and calculated risk-standardized rates of cardiac arrest survival for hospitals with a minimum of 10 pediatric cardiac arrest cases. A total of 13 patient-level predictors were identified: age, sex, cardiac arrest rhythm, location of arrest, mechanical ventilation, acute nonstroke neurological event, major trauma, hypotension, metabolic or electrolyte abnormalities, renal insufficiency, sepsis, illness category, and need for intravenous vasoactive agents prior to the arrest. The model had good discrimination (C-statistic of 0.71), confirmed by bootstrap validation (validation C-statistic of 0.69). Among 30 hospitals with =10 cardiac arrests, unadjusted hospital survival rates varied considerably (median, 37%; interquartile range, 24- 42%; range, 0-61%). After risk-standardization, the range of hospital survival rates narrowed (median, 37%; interquartile range, 33-38%; range, 29-48%), but variation in survival persisted. Conclusions-Using a national registry, we developed and validated a model to predict survival after in-hospital cardiac arrest in children. After risk-standardization, significant variation in survival rates across hospitals remained. Leveraging these models, future studies can identify best practices at high-performing hospitals to improve survival outcomes for pediatric cardiac arrest. © 2014 American Heart Association, Inc. Source


Kolar J.C.,Medical City Childrens Hospital | Salter E.M.,University of Texas at Dallas | Weinberg S.M.,University of Pittsburgh
Journal of Craniofacial Surgery | Year: 2010

Although clinical descriptions of altered calvarial shape in isolated sagittal synostosis abound in the literature, systematic quantitative assessment of the total morphologic pattern of preoperative craniofacial dysmorphology remains limited in this population. To address this deficit, a retrospective study was undertaken of 256 preoperative patients younger than 6 years with isolated sagittal synostosis who were seen at the Dallas Craniofacial Center. Patients were examined using a battery of 23 anthropometric measurements of the head and face, from which 10 proportion indices were calculated. The measurements and proportions for each patient were compared with sex- and age-matched norms and converted to standard (Z) scores. The pooled data for each variable were analyzed using 1-sample t-tests. The patients were then separated into 2 age groups-younger than 6 months (n = 162) and 6 months or older (n = 94)-and compared via 2-sample t-tests to examine age-related differences. To further elucidate craniofacial growth patterns, standardized anthropometric measures were then correlated against age. Results indicated that the head was enlarged and elongated with compensatory transverse growth of the anterior cranial vault and reduction in the height of vertex. The face was enlarged, especially along the sagittal axis. The head and face were significantly larger relative to age in children younger than 6 months and show a general decrease in size relative to age in all dimensions except cranial length. The data indicate a complex pattern of dysmorphology, which involves the entire craniofacial complex, not just the cranial vault. Copyright © 2010 by Mutaz B. Habal, MD. Source


Raymond T.T.,Medical City Childrens Hospital | Sales G.,Childrens Medical Center Dallas | Morris M.C.,Childrens Hospital of New York Presbyterian
Pediatrics | Year: 2010

OBJECTIVE: When prospective informed consent is not feasible, clinical research that presents more than minimal risk can proceed only with an exception from informed consent. Our objectives were (1) to describe the inhospital community consultation and public disclosure process for a clinical trial and (2) to evaluate our inhospital public disclosure process. METHODS: Community consultation included parents, providers, and administrators in a PICU via focus groups, conferences, and other methods. Public disclosure consisted of a brochure and a poster in all PICU waiting rooms. These materials described risks and benefits of the trial, that no consent would be sought, howto "opt out," and howto provide feedback. A verbal questionnaire was administered to parents of potential patients during the trial to evaluate the public disclosure process. RESULTS: Eighty-one percent of 93 parents were aware of the ongoing trial. Seventy-six of 93 remembered seeing the brochure; of these, 26% did not read, 39% read quickly, and 35% read carefully. Thirty-seven of 93 parents remembered seeing the poster; of these, 51% did not read, 32% read quickly, and 17% read carefully. Sixty-seven percent reported that they would want to participate in the study, 9% would not, and 24% were undecided. Of the 7 parents who did not want to participate, 3 had opted out and 4 were unaware that they could opt out. CONCLUSIONS: Parents endorsed resuscitation research with an exception from informed consent. Public disclosure yielded >80% parental awareness. Efforts should be made to ensure awareness of the ability to opt out. Source


Goldman S.,Medical City Childrens Hospital | Smith L.,University of Nebraska at Omaha | Galardy P.,Mayo Medical School | Perkins S.L.,University of Utah | And 9 more authors.
British Journal of Haematology | Year: 2014

Children and adolescents with Burkitt Lymphoma (BL) and combined central nervous system (CNS) and bone marrow involvement still have a poor prognosis with chemotherapy alone. We therefore investigated in children and adolescents with bone marrow (≥25% blasts) and/or CNS-positive Burkitt lymphoma the chemoimmunotherapy combination of rituximab (375 mg/m2) and the standard chemotherapy arm of our previously reported French-American-British (FAB) Lymphome Malins de Burkitt (LMB) 96 trial. Central pathological and cytogenetic characterization was also performed. There were 40 evaluable patients with Burkitt histology (25 with leukaemia and 15 with CNS disease ± leukaemia). The chemoimmunotherapy regimen was well tolerated. The incidence of grade III/IV mucositis during induction cycles with combined chemotherapy and rituximab was 31% and 26%, respectively. The 3-year event-free survival (EFS)/overall survival (OS) was 90% (95% confidence interval [CI], 76-96%) in the entire cohort and 93% (95% CI, 61-99%) in patients with CNS disease. Based on the results of this trial, an international randomized study of FAB/LMB 96 chemotherapy ± rituximab for high-risk patients is currently under investigation. © 2014 John Wiley & Sons Ltd. Source


Wasserman R.L.,Medical City Childrens Hospital | Melamed I.,e International Research Centers | Nelson R.P.,Indiana University | Knutsen A.P.,University Institute of Health Sciences | And 4 more authors.
Clinical Pharmacokinetics | Year: 2011

Background and Objectives: Immunoglobulin replacement is a standard therapy for patients with primary immunodeficiencies. Subcutaneous administration of immunoglobulin offers more constant IgG levels than intravenous administration and simplifies administration for some patients. Use of L-proline as an excipient contributes to the stability of highly concentrated IgG preparations. The aims of the present study were to evaluate the pharmacokinetics of IgPro20 (Hizentra®), a new 20%subcutaneous IgG solution, and compare the area under the serum concentration-time curve (AUC) with that of a similar intravenous 10% IgG solution (IgPro10; Privigen®). At the request of the US FDA, an algorithm for determining IgG trough level ratios (TLRs) was developed in order to provide physicians with a practical tool for monitoring doses during steady-state IgPro20 therapy. Methods: This was a prospective, open-label, multicentre, single-arm, phase III clinical trial conducted in the US. The study was performed in a primary-care setting. Eligible patients were males or females aged 6-75 years with a primary immunodeficiency (common variable immunodeficiency or X-linked agammaglobulinaemia) who had received regular treatment with IgPro10 for at least 3 months prior to entering this study and had achieved serum trough concentration (Ctrough) values ‡5g/L. IgPro20 was administered subcutaneously once weekly at initial doses equivalent to 130% of patients' previous doses, based on the results obtained in a Vivaglobin® study and due to an FDA request. After runin, each patient's dose was adjusted to achieve an AUC comparable to that achieved with IgPro10 administered intravenously. Results: Eighteen patients completed the study. Mean IgPro20 : IgPro10 dose ratio (dose adjustment coefficient) was 1.53 (range 1.26-1.87). The resulting mean AUCs were 105.6 g®day/L for IgPro20 versus 103.2 ®day/L for IgPro10 (geometric mean ratio 1.002; lower one-sided 95% confidence limit [CL] 0.951). Thus, the primary endpoint of the study was met, as this result exceeded the pre-specified criterion of the lower one-sided 95% CL of ≥0.8 for non-inferiority. At these AUCs, which were considered equivalent, the mean IgPro20 : IgPro10 TLR, determined by the developed algorithm, was 1.29 (range 1.18-1.73). Titres of specific antibodies tested were well above respective product specifications, suggesting that protection against infection would be effective. Conclusion: Steady-state AUCs with subcutaneous IgPro20 and intravenous IgPro10 were equivalent. Mean dose adjustment coefficient and mean TLR can be used for initial dose conversion without risk of underprotection but vary too widely to be considered measures of equivalence. © 2011 Adis Data Information BV. All rights reserved. Source

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