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Mason K.P.,Boston Childrens Hospital | Lubisch N.,Chris Evert Childrens Hospital | Robinson F.,DM Statistics Inc. | Roskos R.,Chris Evert Childrens Hospital | Epstein M.A.,Chris Evert Childrens Hospital
Journal of Pediatrics | Year: 2012

Objectives: To describe the efficacy and outcome of dexmedetomidine (Dex) via the intramuscular (IM) route for sedation for electroencephalography (EEG). Study design: Quality assurance data and EEG studies were reviewed for consecutive patients who received IM Dex for EEGs between August 2007 and September 2009. Sleep spindles, delta waves, and beta activity were evaluated to determine the deepest stage of sleep achieved. Results: One hundred seven consecutive children (age 0.2-17 years) between August 2007 and September 2009 received IM Dex (range 1.0-4.5 mcg/kg). The average time to achieve sedation was 15.5 minutes (range 3.0-55.0) with an average of 54.5 minutes to meet discharge criteria following EEG studies, which averaged 34.2 ± 22.6 minutes. The deepest stage of sleep recorded for each child was: awake (n = 1), stage N2 (n = 51), and stage N3 (n = 55). Excessive beta activity was seen in only 1 patient. Epileptiform activity was noted in 11 patients. Hemodynamic fluctuations in heart rate and blood pressure were noted, none of which required pharmacologic intervention. All EEGs were successfully completed. Conclusion: We describe Stage 3 sleep and preserved background activity in response to Dex. We present the IM route as a new method, which preserves background EEG activity to provide safe and effective sedation for EEG studies. Copyright © 2012 Mosby Inc. Source


Dukes K.A.,DM Statistics Inc. | Burd L.,University of North Dakota | Elliott A.J.,Center for Health Outcomes and Prevention | Fifer W.P.,Columbia University | And 15 more authors.
Paediatric and Perinatal Epidemiology | Year: 2014

Background: The Safe Passage Study is a large, prospective, multidisciplinary study designed to (1) investigate the association between prenatal alcohol exposure, sudden infant death syndrome (SIDS), and stillbirth, and (2) determine the biological basis of the spectrum of phenotypic outcomes from exposure, as modified by environmental and genetic factors that increase the risk of stillbirth, SIDS, and in surviving children, fetal alcohol spectrum disorders. Methods: The results provided are based on an interim assessment of 6004 women enrolled, out of the 12 000 projected, from the Northern Plains, US, and Cape Town, South Africa, areas known to be of high risk for maternal drinking during pregnancy. Research objectives, study design, and descriptive statistics, including consent, recruitment, and retention information, are provided. Results: Overall visit compliance is 87%, and includes prenatal, delivery/newborn, and postnatal contacts through 1 year post-delivery. Pregnancy outcome ascertainment is 98% prior to medical chart review; less than 2% of women withdraw. Consent for the use of DNA and placental tissueexceed 94%, and consent to participate in the autopsy portion of the study is 71%. Conclusions: The Safe Passage Study is the first multi-site study of SIDS and stillbirth to integrate prospectively collected exposure information with multidisciplinary biological information in the same maternal and fetal/ infant dyad using a common protocol. Essential components of the study design and its success are close ties to the community and rigorous systems and processes to ensure compliance with the study protocol and procedures. © 2014 John Wiley & Sons Ltd. Source


Merlini G.,University of Pavia | Plante-Bordeneuve V.,CHU Henri Mondor | Judge D.P.,Johns Hopkins University | Schmidt H.,Universitatsklinikum Munster | And 5 more authors.
Journal of Cardiovascular Translational Research | Year: 2013

This phase II, open-label, single-treatment arm study evaluated the pharmacodynamics, efficacy, and safety of tafamidis in patients with non-Val30Met transthyretin (TTR) amyloidosis. Twenty-one patients with eight different non-Val30Met mutations received 20 mg QD of tafamidis meglumine for 12 months. The primary outcome, TTR stabilization at Week 6, was achieved in 18 (94.7 %) of 19 patients with evaluable data. TTR was stabilized in 100 % of patients with non-missing data at Months 6 (n = 18) and 12 (n = 17). Exploratory efficacy measures demonstrated some worsening of neurological function. However, health-related quality of life, cardiac biomarker N-terminal pro-hormone brain natriuretic peptide, echocardiographic parameters, and modified body mass index did not demonstrate clinically relevant worsening during the 12 months of treatment. Tafamidis was well tolerated. In conclusion, our findings suggest that tafamidis 20 mg QD effectively stabilized TTR associated with several non-Val30Met variants. © 2013 The Author(s). Source


Mason K.P.,Harvard University | Fontaine P.J.,Harvard University | Robinson F.,DM Statistics Inc. | Zgleszewski S.,Harvard University
American Journal of Roentgenology | Year: 2012

OBJECTIVE. Although the demand for pediatric MRI is increasing, it is uncommon to find sedation being offered at community hospital-based outpatient centers. We present our safety, efficacy, and outcome data at a community hospital-based outpatient imaging center. MATERIALS AND METHODS. IV dexmedetomidine sedation was administered as a bolus of 3 μg/kg and maintained with a continuous infusion of 1 μg/kg/hr until imaging was complete. The dexmedetomidine bolus could be repeated up to two times, if needed. Quality assurance data were reviewed. RESULTS. From April 2009 to July 2010, 279 children (mean age, 4.2 years; age range, 0.2-17.2 years) were sedated. All received a first bolus, 46 required a second dose, and two received a third. The average time to achieve sedation was 7.8 minutes (SD, ± 3.8 minutes). Total duration of imaging (82% brain MRI) averaged 38.1 minutes (range, 8.0-126.0 minutes). On average, discharge criteria were met within 21.3 minutes of arrival in recovery room (± 17.8 minutes). The heart rate and blood pressure deviated from baseline by more than 20% in 5% and 33% of the patients, respectively. No pharmacologic therapy was administered to treat the hemodynamic variability. There were no adverse respiratory events. All imaging studies were successfully completed. CONCLUSION. Dexmedetomidine offers an option for pediatric sedation for MRI at community hospital-based outpatient settings. It preserves respiration but elicits deviations in blood pressure and heart rate that have not required pharmacologic intervention. Dexmedetomidine offers a safe, effective, and efficient agent for sedation for children undergoing MRI in an outpatient setting. Source


Bertholet N.,University of Massachusetts Boston | Bertholet N.,University of Lausanne | Cheng D.M.,University of Massachusetts Boston | Cheng D.M.,Boston University | And 5 more authors.
Drug and Alcohol Dependence | Year: 2010

Objective: To understand patterns of alcohol consumption and baseline factors associated with favorable drinking patterns among HIV-infected patients. Methods: We studied drinking patterns among HIV-infected patients with current or past alcohol problems. We assessed drinking status in 6-month intervals. Based on National Institute on Alcohol Abuse and Alcoholism guidelines a favorable drinking pattern was defined as not drinking risky amounts at each assessment or decreased drinking over time. All other patterns were defined as unfavorable. Logistic regression models were used to identify baseline factors associated with a favorable pattern. Results: Among 358 subjects, 54% had a favorable drinking pattern with 44% not drinking risky amounts at every assessment, and 11% decreasing consumption over time. Of the 46% with an unfavorable pattern, 4% drank risky amounts each time, 5% increased, and 37% both decreased and increased consumption over time. Current alcohol dependence and recent marijuana use were negatively associated with a favorable pattern, while older age and female gender, and having a primary HIV risk factor of injection drug use were positively associated with a favorable pattern. Conclusion: Many HIV-infected adults with alcohol problems have favorable drinking patterns over time, and alcohol consumption patterns are not necessarily constant. Identifying HIV-infected adults with a pattern of risky drinking may require repeated assessments of alcohol consumption. © 2010 Elsevier Ireland Ltd. Source

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