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Item Actual and Prescribed Energy and Protein Intakes for Very Low Birth Weight Infants: An Observational Study(Office of the Vice Chancellor for Research, 2013-04-05) Abel, Deborah; Poindexter, Brenda; Denne, Scott; Cruse, Wendy; Engel, William; Rickard, KarylObjectives: To determine (1) whether prescribed and actual energy and protein intakes during the first two weeks of life met Ziegler’s estimated requirements for Very Low Birth Weight (VLBW) infants, (2) if actual energy during the first week of life correlated with time to regain birth weight and reach full enteral nutrition (EN) defined as 100 kcal/kg/day, (3) if growth velocity from time to reach full EN to 36 weeks postmenstrual age (PMA) met Ziegler’s estimated fetal growth velocity, and lastly (4) to examine growth outcomes at 36 weeks PMA. Study design: Observational study of feeding, early nutrition and growth of 40 VLBW infants <30 weeks GA at birth in three tertiary care newborn intensive care units NICUs).Item The Impact of a Growth Measurement Training Program on the Use of Length Boards in a Newborn Intensive Care Unit(2021-07) Thornton, Jessica Lynn; Blackburn, Sara; Denne, Scott; O'Palka, JacquelynnObjective: Nutritional assessment of infants in the Newborn Intensive Care Unit (NICU) depends on the performance of accurate, serial anthropometric measurements. In this Level IV NICU, nurses used tape measures more often than length boards making the length measurements inaccurate. The purpose of this study is to determine if an in-person, hands-on length board training program versus a self-instruction poster education, increases the use of length boards to measure length in NICU infants. Methods: Two nursing in-service education training sessions on how to correctly use a length board were held with the NICU staff over two separate two (2-week) periods. One session consisted of a self-direct education training method. The second education method was an in-person interactive learning experience with hands on practice. At the end of each education session, the participants completed the same four-question post-test. One month later, data was collected for one month following each of the training periods on the tool used to obtain linear measurements on infants in the NICU. Statistics: A 2x2 contingency table was constructed using the two qualitative variables of length board uses after the poster education versus length board uses after the live in-service education. Analysis was performed using SAS 9.4 ™ statistical software. Chi squared equals 93.980 with 1 degree of freedom. P-value <0.0001. Results: The month following the self-directed poster education, two hundred ninety-one (291) or 92% measurements were obtained using a tape measure and 19 (7%) obtained using a length board. The month following the interactive, in-service training, one hundred forty-eight (148) or 57% measurements were obtained using a tape measure and 105 (41%) with a length board. Thirty five percent (35%) more length measurements were obtained using a length board after the line in-service training (P-value <0.0001). Conclusion: Nurses in a Level IV Newborn Intensive Care Unit utilized length boards significantly more after a live in-service education than after a self-directed education.Item A Model for Engaging Public–Private Partnerships(Wiley, 2011-04-04) Shekhar, Anantha; Denne, Scott; Tierney, William; Wilkes, David; Brater, D. Craig; Medicine, School of MedicineItem Pharmacotherapy and pregnancy: Highlights from the first International Conference for Individualized Pharmacotherapy in Pregnancy(Wiley, 2009-02) Haas, David M.; Renbarger, Jamie L.; Denne, Scott; Ahmed, Mahmoud S.; Easterling, Thomas; Feibus, Karen; Meslin, Eric M.; Koren, Gideon; Zajicek, Anne; Snodgrass, Wayne R.; Flockhart, David A.; Medicine, School of MedicineData are sparse on the effects of medication use during pregnancy. Half of the world's population is women. The majority of women become pregnant, and many of those women take some kind of medication during their pregnancy, even if only for a short time. The majority of drugs have not been rigorously studied in pregnant women to determine the most effective dose with the least potential for adverse effects. Instead, women are given “cookie‐cutter” therapy, using doses extrapolated from nonpregnant women, men, or pregnant animals. This can lead to problems. Instead, individualization of pharmacotherapy in pregnancy promises to take individual women and determine the optimal dose and drug for them to maximize the effect of the drug while attempting to minimize the side effects to them and their unborn babies. Because this field of study is underrepresented, we held a conference to bring together researchers and experts to discuss current knowledge, issues, and challenges surrounding individualized pharmacotherapy in pregnancy. Speakers came from the NIH, the Food and Drug Administration (FDA), and various research centers in the United States and Canada. Below are the summaries of the discussions at the conference. Full notes from the panel discussions are available from the authors on request.Item Recommendations for the design of therapeutic trials for neonatal seizures(Springer Nature, 2019-06) Soul, Janet S.; Pressler, Ronit; Allen, Marilee; Boylan, Geraldine; Rabe, Heike; Portman, Ron; Hardy, Pollyanna; Zohar, Sarah; Romero, Klaus; Tseng, Brian; Bhatt-Mehta, Varsha; Hahn, Cecil; Denne, Scott; Auvin, Stephane; Vinks, Alexander; Lantos, John; Marlow, Neil; Davis, Jonathan M.; Pediatrics, School of MedicineAlthough seizures have a higher incidence in neonates than any other age group and are associated with significant mortality and neurodevelopmental disability, treatment is largely guided by physician preference and tradition, due to a lack of data from well-designed clinical trials. There is increasing interest in conducting trials of novel drugs to treat neonatal seizures, but the unique characteristics of this disorder and patient population require special consideration with regard to trial design. The Critical Path Institute formed a global working group of experts and key stakeholders from academia, the pharmaceutical industry, regulatory agencies, neonatal nurse associations, and patient advocacy groups to develop consensus recommendations for design of clinical trials to treat neonatal seizures. The broad expertise and perspectives of this group were invaluable in developing recommendations addressing: (1) use of neonate-specific adaptive trial designs, (2) inclusion/exclusion criteria, (3) stratification and randomization, (4) statistical analysis, (5) safety monitoring, and (6) definitions of important outcomes. The guidelines are based on available literature and expert consensus, pharmacokinetic analyses, ethical considerations, and parental concerns. These recommendations will ultimately facilitate development of a Master Protocol and design of efficient and successful drug trials to improve the treatment and outcome for this highly vulnerable population.Item Team Science to maximize rapid collection and analyses of biosamples from patients with Covid-19(Cambridge, 2021) Moe, Sharon M.; Patz, Brooke; Liu, Yunlong; Orschell, Christie; Yu, Andy; Denne, Scott; Embi, Peter; Foroud, Tatiana; Medicine, School of MedicineItem The Concordance of Electronic Health Record Diagnoses and Substance use Self-Reports Among Reproductive Aged Women Enrolled in a Community-Based Addiction Reduction Program(Sage, 2024) Campbell, Angela G.; Naz, Saman; Gharbi, Sami; Chambers, Joanna; Denne, Scott; Litzelman, Debra K.; Wiehe, Sarah E.; Pediatrics, School of MedicineSubstance use disorders among reproductive aged women are a major public health issue. There is little work investigating the validity and reliability of electronic health record (EHR) data for measuring substance use in this population. This study examined the concordance of self-reported substance use with clinical diagnoses of substance use, substance abuse and substance use disorder in EHR data. Reproductive age women enrolled in the Community-Based Addiction Reduction (CARE) program were interviewed by peer recovery coaches (PRC) at enrollment. That survey data was linked with EHR data (n = 102). Concordance between self-reported substance use and clinical diagnoses in the EHR was examined for opioids, cannabis/THC, and cocaine. Cohen's kappa, sensitivity, and specificity were calculated. The survey captured a higher number of women who use substances compared to the EHR. The concordance of self-report with EHR diagnosis varied by substance and was higher for opioids (17.6%) relative to cannabis/THC (8.8%), and cocaine (3.0%). Additionally, opioids had higher sensitivity (46.2%) and lower specificity (76.2%) relative to cannabis/THC and cocaine. Survey data collected by PRCs captured more substance use than EHRs, suggesting that EHRs underestimate substance use prevalence. The higher sensitivity and lower specificity of opioids was due to a larger number of women who had a diagnosis of opioid use in the EHR who did not self-report opioid use in the self-report survey relative to cannabis/THC and cocaine. Opioid self-report and diagnosis may be influenced by research setting, question wording, or receipt of medication for opioid use disorder.