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Beal J.,U.S. Food and Drug Administration | Silverman B.,U.S. Food and Drug Administration | Bellant J.,Providence St Vincent Medical Center | Young T.E.,University of North Carolina at Chapel Hill | Klontz K.,U.S. Food and Drug Administration
Journal of Pediatrics

Adverse event reports submitted to the US Food and Drug Administration suggested a possible association between necrotizing enterocolitis and ingestion of a commercial feed thickener by premature infants. Review in 2011 of 22 cases with exposure revealed a distinct illness pattern. Copyright © 2012 Mosby Inc. Source

Nguyen-Vermillion A.,Providence St Vincent Medical Center | Juul S.E.,University of Washington | McPherson R.J.,University of Washington | Ledbetter D.J.,University of Washington
Journal of Pediatrics

Objective: To characterize the perioperative course of C-reactive protein (CRP) and inflammatory mediators in neonates ≤44 weeks' corrected gestational age. Study design: Prospective study of CRP and inflammatory mediators interleukin (IL)-1β, IL-6, IL-8, IL-10, and tumor necrosis factor-α in 55 neonates undergoing thoracic or abdominal surgery. Results: In the absence of infection, CRP increased after surgery, peaking on post-operative day 2. The perioperative patterns of CRP differed by diagnosis and inflammatory state. Surgery alone did not cause an increase in CRP because in 13 of 55 infants (24%), CRP remained <1.0 mg/dL at all time points. For thoracic procedures, patent ductus arteriosus ligation showed the least post-operative increase in CRP, and patients undergoing repair of congenital diaphragmatic hernia or tracheoesophageal fistula had a greater response. Abdominal procedures with low CRP response included repair of imperforate anus and pyloric stenosis, while gastroschisis repair and bowel reanastomosis after necrotizing enterocolitis were accompanied by a robust CRP response. IL-6 concentrations peaked on post-operative day 1 and correlated with the post-operative day 2 CRP peak (r = 0.398, P = .004). The additional inflammatory mediators measured were not informative. Conclusions: The range and time course of perioperative CRP differ by diagnosis. Serial measurements may be more informative than CRP magnitude. Copyright © 2011 Mosby Inc. All rights reserved. Source

Wen M.-J.,National Defense Medical Center | Sung C.-C.,National Defense Medical Center | Chau T.,Providence St Vincent Medical Center | Lin S.-H.,National Defense Medical Center
Clinical Nephrology

Ertapenem, a novel carbapenem with long-acting antimicrobial activity, is predominantly eliminated by the kidneys. Acute prolonged neurotoxicity associated with recommended doses of ertapenem in patients with advanced renal failure not yet on dialysis has not been reported. Two patients with Stage 5 chronic kidney disease (CKD) developed progressive hallucinations, asterixis, myoclonic jerks, and cognitive impairment after receiving the recommended dose reduction for CKD of ertapenem (500 mg/d) for 4 days (Case 1: acute cholecystitis) and 5 days (Case 2: arteriovenous fistula infection). Exhaustive diagnostic workups were non-revealing. Plasma ertapenem level measured 24 h after the last dose in Patient 2 was 53.7 mg/l, much higher than the therapeutic MIC90 (2 mg/l). Despite the cessation of ertapenem and initiation of high-flux hemodialysis, their neurologic manifestations lasted for 2 weeks. The structural and pharmacokinetic characteristics of ertapenem such as its high lipophilicity, central nervous penetration, and volume of distribution contributed to sustained neurotoxicity even with significant reduction in plasma ertapenem levels by high-flux hemodialysis. Although ertapenem 500 mg/d has been recommended in patients with glomerular filtration rate less than 30 ml/min/1.73 m2, our 2 cases highlight that this dosage might be excessive for patients with Stage 5 CKD, especially those not yet on dialysis. ©2013 Dustri-Verlag Dr. K. Feistle. Source

Veltman L.,Providence St Vincent Medical Center
Journal of healthcare risk management : the journal of the American Society for Healthcare Risk Management

In 1996, Wachter and Goldman described a new model of care in which hospital-based physicians provided patients' inpatient care in lieu of the patient's primary physician.(1) They termed these physicians hospitalists. The hospitalist movement had taken hold, and by 1999, 65% of internists had hospitalists in their community and 28% reported using them for inpatient care.(2) In 2003, Louis Weinstein, in an article entitled "The Laborist: A New Focus of Practice for the Obstetrician"(3) advocated for the adoption of the hospitalist model to obstetrical care. In a 2010 study, of 28,545 members of the American College of Obstetricians and Gynecologists (ACOG) contacted in a national survey, 7,044 clinicians responded, which yielded a response rate of 25%. Of the respondents, 1,020 clinicians (15% of respondents, 3.6% of the entire sample) described themselves as obstetrics/gynecology hospitalists or laborists.(4) According to the web site www.obgynhospitalist.com, there are at least 115 hospitals in the country that utilize a laborist or OB hospitalist model of care.(5). © 2011 American Society for Healthcare Risk Management of the American Hospital Association. Source

Dunn M.S.,University of Toronto | Kaempf J.,Providence St Vincent Medical Center | De Klerk A.,Florida Hospital Memorial Medical Center | De Klerk R.,Florida Hospital Memorial Medical Center | And 5 more authors.

OBJECTIVE: We designed a multicenter randomized trial to compare 3 approaches to the initial respiratory management of preterm neonates: prophylactic surfactant followed by a period of mechanical ventilation (prophylactic surfactant [PS]); prophylactic surfactant with rapid extubation to bubble nasal continuous positive airway pressure (intubate-surfactant-extubate [ISX]) or initial management with bubble continuous positive airway pressure and selective surfactant treatment (nCPAP). DESIGN/METHODS: Neonates born at 260/7 to 296/7 weeks' gestation were enrolled at participating Vermont Oxford Network centers and randomly assigned to PS, ISX, or nCPAP groups before delivery. Primary outcome was the incidence of death or bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age. RESULTS: 648 infants enrolled at 27 centers. The study was halted before the desired sample size was reached because of declining enrollment. When compared with the PS group, the relative risk of BPD or death was 0.78 (95% confidence interval: 0.59-1.03) for the ISX group and 0.83 (95% confidence interval: 0.64-1.09) for the nCPAP group. There were no statistically significant differences in mortality or other complications of prematurity. In the nCPAP group, 48% were managed without intubation and ventilation, and 54% without surfactant treatment. CONCLUSIONS: Preterm neonates were initially managed with either nCPAP or PS with rapid extubation to nCPAP had similar clinical outcomes to those treated with PS followed by a period of mechanical ventilation. An approach that uses early nCPAP leads to a reduction in the number of infants who are intubated and given surfactant. Copyright © 2011 by the American Academy of Pediatrics. Source

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