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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 | Year: 2012

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.


Frye A.M.,Providence St Vincent Medical Center | Baker C.A.,Providence St Vincent Medical Center | Rustvold D.L.,Center for Outcomes Research and Education | Heath K.A.,Providence Portland Medical Center | And 4 more authors.
Journal of Clinical Microbiology | Year: 2012

The purpose of this study was to evaluate the impact of real-time PCR reporting both on timely identification of clustered Gram-positive cocci (GPC) in blood cultures and on appropriate antibiotic treatment. This retrospective, interventional cohort study evaluated inpatients with blood cultures positive for GPC in the pre-PCR (15 January 2009 to 14 January 2010) and post-PCR (15 January 2010 to 14 January 2011) periods. Post-PCR implementation, laboratory services completed batched PCR; results other than methicillin-resistant Staphylococcus aureus (MRSA) were reported in the electronic medical record without additional interventions. The assay's sensitivity and specificity, time to identification of staphylococcal bacteremia, and clinically relevant outcomes, including time to optimal antibiotic therapy, were evaluated. Demographic information was also collected and analyzed. Sixty-eight and 58 patients with Staphylococcus aureus bacteremia from the pre- and post-PCR periods, respectively, met inclusion criteria. Similar numbers of consecutive patients with coagulase-negative staphylococci were analyzed for comparison. The time to identification was significantly reduced post-PCR implementation (mean, 13.2 h; 95% confidence interval [95% CI], 10.5 to 15.9 h; P < 0.0001). However, the time to optimal antibiotic therapy was not significantly reduced. We conclude that implementation of a PCR assay demonstrated the potential to improve appropriate antibiotic use based on clinically meaningful and statistically significant reductions in the time to microbiologic identification. However, in order to realize this potential benefit, processes must be optimized and additional interventions initiated to facilitate providers' use of the PCR result. Copyright © 2012, American Society for Microbiology. All Rights Reserved.


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.
Pediatrics | Year: 2011

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.


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 | Year: 2011

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.


Kaempf J.W.,Providence St Vincent Medical Center | Tomlinson M.W.,Providence St Vincent Medical Center | Kaempf A.J.,Providence St Vincent Medical Center | Wu Y.,Providence St Vincent Medical Center | And 3 more authors.
Obstetrics and Gynecology | Year: 2012

OBJECTIVE:: Delayed umbilical cord clamping is reported to increase neonatal blood volume. We estimated the clinical outcomes in premature neonates who had delayed umbilical cord clamping compared with a similar group who had early umbilical cord clamping. METHODS:: This was a before-after investigation comparing early umbilical cord clamping with delayed umbilical cord clamping (45 seconds) in two groups of singleton neonates, very low birth weight (VLBW) (401-1,500 g) and low birth weight (LBW) (greater than 1,500 g but less than 35 weeks gestation). Neonates were excluded from delayed umbilical cord clamping if they needed immediate major resuscitation. Primary outcomes were provision of delivery room resuscitation, hematocrit, red cell transfusions, and the principle Vermont Oxford Network outcomes. RESULTS:: In VLBW neonates (77 delayed umbilical cord clamping, birth weight [mean±standard deviation] 1,099±266 g; 77 early umbilical cord clamping 1,058±289 g), delayed umbilical cord clamping was associated with less delivery room resuscitation, higher Apgar scores at 1 minute, and higher hematocrit. Delayed umbilical cord clamping was not associated with significant differences in the overall transfusion rate, peak bilirubin, any of the principle Vermont Oxford Network outcomes, or mortality. In LBW neonates (172 delayed umbilical cord clamping, birth weight [mean±standard deviation] 2,159±384 g; 172 early umbilical cord clamping 2,203±447 g), delayed umbilical cord clamping was associated with higher hematocrit and was not associated with a change in delivery room resuscitation or Apgar scores or with changes in the transfusion rate or peak bilirubin. Regression analysis showed increasing gestational age and birth weight and delayed umbilical cord clamping were the best predictors of higher hematocrit and less delivery room resuscitation. CONCLUSION:: Delayed umbilical cord clamping can safely be performed in singleton premature neonates and is associated with a higher hematocrit, less delivery room resuscitation, and no significant changes in neonatal morbidities. I© 2012 by Lippincott Williams & Wilkins.


Wen M.-J.,Tri Service General Hospital | Sung C.-C.,Tri Service General Hospital | Chau T.,Providence St Vincent Medical Center | Lin S.-H.,Tri Service General Hospital
Clinical Nephrology | Year: 2013

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.


Veltman L.,Providence St Vincent Medical Center
Journal of healthcare risk management : the journal of the American Society for Healthcare Risk Management | Year: 2013

Underwater birthing has become a popular birth practice in some areas of the country. Although many of these deliveries occur in a home birth setting, the practice has also been implemented in hospitals and birthing centers. There is continued controversy about the risks and benefits of underwater birthing (as opposed to hydrotherapy during labor), and many risk managers are unaware of these potential risks and benefits. The purpose of this article is to review the significant risks and benefits of underwater birthing, to review relevant literature and several Professional Organizations' Position Statements regarding underwater birthing, and to provide a safety checklist for hospital risk managers who wish to consider adding underwater birthing to their current scope of perinatal care. © 2013 American Society for Healthcare Risk Management of the American Hospital Association.


Kaempf J.W.,Providence St Vincent Medical Center | Wu Y.X.,Providence St Vincent Medical Center | Kaempf A.J.,Providence St Vincent Medical Center | Kaempf A.M.,Providence St Vincent Medical Center | And 2 more authors.
Journal of Perinatology | Year: 2012

Objective: It remains unclear whether indomethacin (INDO) and/or surgical ligation (LIGATE) are necessary to improve outcomes in premature infants with a patent ductus arteriosus (PDA). We have adopted a conservative approach to PDA management that emphasizes waiting for spontaneous closure unless certain cardiorespiratory distress criteria are met. Study Design: This was a before-after observational study in infants born 501 to 1500 g in two distinct epochs. Era 1 (January 2005 to December 2007) featured traditional management with INDO and LIGATE used early to close all moderate and large PDAs in infants receiving any respiratory support. Era 2 (January 2008 to June 2009) emphasized modest fluid restriction, watchful waiting and limited INDO and LIGATE to only those infants with large PDAs who met certain cardiorespiratory distress criteria. Result: Era 1 included 139 infants with a PDA, mean (s.d.) gestational age 27.5 (2) weeks; Era 2 72 infants, mean (s.d.) gestational age 27.5 (2) weeks. In Era 2, INDO use significantly decreased (79% of infants to 26%, P < 0.001), and 28 day total fluids decreased (140 vs. 130 ml kg -1 day -1, P < 0.001). LIGATE rate was 45% in Era 1, 33% in Era 2 (P = 0.11). There were no significant differences in supplemental oxygen, nasal continuous positive airway pressure, or mechanical ventilation days. There were no significant differences in mortality or individual morbidities. The combined outcome of chronic lung disease (CLD) or mortality after Day 7 significantly increased (Era 1, 40%, Era 2, 54%, P = 0.04). More infants were discharged home with a PDA in Era 2, but most resolved spontaneously and the need for closure therapy after discharge from the neonatal intensive care unit (NICU) did not increase. Multiple regression analysis demonstrated Era 2 management did not predict an increased risk of one or more interlinked morbidities. Conclusion: Tolerance of the PDA with watchful waiting for spontaneous closure, modest fluid reduction, and less INDO use is a reasonable treatment strategy that is not associated with significant changes in NICU mortality or individual morbidities. We did note an increase in the combined outcome of CLD or mortality after Day 7, thus our investigation supports the urgency of a randomized controlled trial comparing traditional PDA management with a true control group similar to our Era 2 management to answer important questions of short and long-term outcomes. © 2012 Nature America, Inc. All rights reserved.


Migaki E.A.,Providence St Vincent Medical Center | Melhart B.J.,Providence St Vincent Medical Center | Dewar C.J.,Aultman Hospital | Huston R.K.,Childrens Hospital at Legacy Emanuel Medical Center
Journal of Parenteral and Enteral Nutrition | Year: 2012

Objectives: The objectives were to determine concentrations of calcium chloride (CaCl) and sodium phosphate (NaPhos) that can be safely added to TrophAmine-based parenteral nutrition (PN) and to measure aluminum (Al) concentrations in PN solutions containing CaCl and NaPhos vs those containing calcium gluconate (CaGlu) and potassium phosphate (KPhos). Methods: In study A, PN solutions containing varying amounts of TrophAmine, CaCl, and NaPhos were compounded and then evaluated visually for precipitation. In study B, Al concentrations were measured in PN solutions containing CaCl and NaPhos (S1), CaGlu and NaPhos (S2), or CaGlu and KPhos (S3). Results: Study A showed that a maximum phosphorus concentration of 15 mmol/L could be added to a solution containing 12.5 mmol/L of calcium without evidence of precipitation when the amino acid (AA) concentration reached ≥3 g/dL (3%). In study B, the mean (range) Al concentrations were S1 = 2.2 (1.9-2.4), S2 = 8.5 (7.8-9.3), and S3 = 11.7 (10.8-12.2) μmol/L (means of 6.0, 22.9, and 31.5 micrograms/dL, respectively). Conclusions: The data can provide a guide for compounding neonatal PN solutions containing TrophAmine, CaCl, and NaPhos. More studies are needed to determine the long-term effects of substituting CaCl for CaGlu in PN solutions for neonates. Substituting CaCl and NaPhos for CaGlu and KPhos significantly decreases Al concentrations in PN and potential Al exposure of neonatal patients. © 2012 American Society for Parenteral and Enteral Nutrition.


Veltman L.,Providence St Vincent Medical Center
Journal of healthcare risk management : the journal of the American Society for Healthcare Risk Management | Year: 2011

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.

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