Digital Commons Network^™

Utilizing Real-Time Technology To Assess The Impact Of Home Environmental Exposures On Asthma Symptoms: Protocol For An Observational Pilot Study., Sharmilee Nyenhuis, Emily Cramer, Matthew Grande, Luz Huntington-Moskos, Kathryn Krueger, Olivia Bimbi, Barbara Polivka, Kamal Eldeirawi

Manuscripts, Articles, Book Chapters and Other Papers

Background: It is estimated that over 60% of adults with asthma have uncontrolled symptoms, representing a substantial health and economic impact. The effects of the home environment and exposure to volatile organic compounds (VOCs) and fine particulate matter (PM2.5) on adults with asthma remain unknown. In addition, methods currently used to assess the home environment do not capture real-time data on potentially modifiable environmental exposures or their effect on asthma symptoms.

Objective: The aims of this study are to (1) determine the feasibility and usability of ecological momentary assessment (EMA) to assess self-report residential environmental exposures and asthma symptoms, home …

Evaluating The Efficacy Of The Hitsystem 2.1 To Improve Pmtct Retention And Maternal Viral Suppression In Kenya: Study Protocol Of A Cluster-Randomized Trial., Sharon Mokua, May Maloba, Catherine Wexler, Kathy Goggin, Vincent S. Staggs, Natabhona Mabachi, Nicodemus Maosa, Shadrack Babu, Emily A. Hurley, Sarah Finocchario-Kessler

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Gaps in the provision of guideline-adherent prevention of mother-to-child transmission of HIV (PMTCT) services and maternal retention in care contribute to nearly 8000 Kenyan infants becoming infected with HIV annually. Interventions that routinize evidence-based PMTCT service delivery and foster consistent patient engagement are essential to eliminating mother-to-child transmission of HIV. The HITSystem 2.1 is an eHealth intervention that aims to improve retention in PMTCT services and viral load monitoring, using electronic alerts to providers and SMS to patients. This study will evaluate the impact, implementation, and cost-effectiveness of HITSystem 2.1.

METHOD: This cluster randomized trial will be conducted at …

Characterization Of The Mucosally-Adherent Duodenal Microbiome In Children With And Without Crohn's Disease., Kenneth Schmidt, Janelle R. Noel-Macdonnell Phd, Carrie Vyhlidal, Daniel P. Heruth, Vivekanand Singh, Atif A. Ahmed, Taina Hudson, Veronica Williams, Valentina Shakhnovich

Manuscripts, Articles, Book Chapters and Other Papers

Manipulation of the microbiome is a rational treatment strategy for inflammatory bowel disease (IBD). Compared to the colon and terminal ileum (TI), understanding of the microbial composition in the duodenum is sparse. This gap in knowledge is especially significant for children with Crohn's disease (CD) because the prevalence of duodenal CD is higher in children than in adults. Our aim was to characterize the bacterial composition of the mucosally-adherent duodenal microbiome in children with and without CD as a first step toward development of targeted IBD treatment strategies at this disease location. Fresh-frozen mucosal biopsies were obtained from the duodenum …

Effect Of Various Preterm Infant Milk Formulas On Nec-Like Gut Injury In Mice., Karishma Rao, Alain Cuna, Susana Chavez-Bueno, Heather Menden, Wei Yu, Ishfaq Ahmed, Pugazhendhi Srinivasan, Shahid Umar, Venkatesh Sampath

Manuscripts, Articles, Book Chapters and Other Papers

Formula feeding is an important risk factor for the development of necrotizing enterocolitis in preterm infants. The potential harmful effects of different preterm formulas on the developing intestinal tract remain incompletely understood. Here we demonstrate that feeding newborn mouse pups with various preterm formulas resulted in differing effects on intestinal inflammation, apoptosis, and activation of the pro-inflammatory transcription factor NFκB. 16S rRNA sequencing revealed that each preterm formula resulted in significant gut microbial alterations that were different from dam-fed controls. Formula feeding with EleCare and Similac Special Care caused greater intestinal injury compared to NeoSure. Pre-treatment with Lactobacillus rhamnosus GG …

The Neglected Price Of Pediatric Acute Kidney Injury: Non-Renal Implications., Chetna K. Pande, Mallory B. Smith, Danielle E. Soranno, Katja M. Gist, Dana Y. Fuhrman, Kristin Dolan, Andrea L. Conroy, Ayse Akcan-Arikan

Manuscripts, Articles, Book Chapters and Other Papers

Preclinical models and emerging translational data suggest that acute kidney injury (AKI) has far reaching effects on all other major organ systems in the body. Common in critically ill children and adults, AKI is independently associated with worse short and long term morbidity, as well as mortality, in these vulnerable populations. Evidence exists in adult populations regarding the impact AKI has on life course. Recently, non-renal organ effects of AKI have been highlighted in pediatric AKI survivors. Given the unique pediatric considerations related to somatic growth and neurodevelopmental consequences, pediatric AKI has the potential to fundamentally alter life course outcomes. …

Congenital Co-Infections Among Hiv-Exposed Infants Born To Mothers On Antiretroviral Treatment In The United States., Christiana Smith, Lori Silveira, Megan Crotteau, Krystle Garth, Jennifer Canniff, Kirk B. Fetters, Sarah Lazarus, Shannon Capraro, Adriana Weinberg, Chip Perinatal Team

Manuscripts, Articles, Book Chapters and Other Papers

Background: Many women living with HIV (WLHIV) are co-infected with cytomegalovirus (CMV), Toxoplasma gondii (T gondii), and/or hepatitis C virus (HCV). The rates of congenital or perinatal transmission of these co-infections are not well defined in the current era, when most WLHIV receive antiretroviral therapy (ART) during pregnancy.

Methods: Retrospective review of infants of WLHIV born between 2009-2019. Mothers were screened for antibodies to CMV, T. gondii, and HCV; chronic HCV infection was confirmed using plasma RNA PCR. Infants whose mothers had positive/unknown serostatus were screened for CMV using urine or saliva DNA PCR or culture at ≤3 …

Global Health Electives In The Covid-19 Era: Resuming Travel And Strengthening Global Health Academic Partnerships., Heather Haq, Amos Msekandiana, Mogomotsi Matshaba, Linoeo Thahane, Jennifer Watts, Reena Tam, Nicole St Clair, Charles Schubert, Amy Rule, Pia Pannaraj, Michael Pitt, David Oleson, Brittany Murray, Lee Morris, Joanne Mendoza, Megan Mchenry, Elizabeth Keating, Kathy Ferrer, Heather Crouse, Tania Condurache, Maneesh Batra, Adelaide Barnes, James Conway

Manuscripts, Articles, Book Chapters and Other Papers

No abstract provided.

Cross-Reactive Immunity Against The Sars-Cov-2 Omicron Variant Is Low In Pediatric Patients With Prior Covid-19 Or Mis-C., Juanjie Tang, Tanya Novak, Julian Hecker, Gabrielle Grubbs, Fatema Tuz Zahra, Lorenza Bellusci, Sara Pourhashemi, Janet Chou, Kristin Moffitt, Natasha B. Halasa, Stephanie P. Schwartz, Tracie C. Walker, Keiko M. Tarquinio, Matt S. Zinter, Mary A. Staat, Shira J. Gertz, Natalie Z. Cvijanovich, Jennifer E. Schuster, Laura L. Loftis, Bria M. Coates, Elizabeth H. Mack, Katherine Irby, Julie C. Fitzgerald, Courtney M. Rowan, Michele Kong, Heidi R. Flori, Aline B. Maddux, Steven L. Shein, Hillary Crandall, Janet R. Hume, Charlotte V. Hobbs, Adriana H. Tremoulet, Chisato Shimizu, Jane C. Burns, Sabrina R. Chen, Hye Kyung Moon, Christoph Lange, Adrienne G. Randolph, Surender Khurana

Manuscripts, Articles, Book Chapters and Other Papers

Neutralization capacity of antibodies against Omicron after a prior SARS-CoV-2 infection in children and adolescents is not well studied. Therefore, we evaluated virus-neutralizing capacity against SARS-CoV-2 Alpha, Beta, Gamma, Delta and Omicron variants by age-stratified analyses (5 years of age. As expected, convalescent pediatric COVID-19 and MIS-C cohorts demonstrate higher neutralization titers than hospitalized acute COVID-19 patients. Overall, children and adolescents show some loss of cross-neutralization against all variants, with the most pronounced loss against Omicron. In contrast to SARS-CoV-2 infection, children vaccinated twice demonstrated higher titers against Alpha, Beta, Gamma, Delta and Omicron. These findings can influence transmission, re-infection …

Differentially Methylated Cpgs In Response To Growth Hormone Administration In Children With Idiopathic Short Stature., Xiaojian Shao, Catherine Le Stunff, Warren A. Cheung, Tony Kwan, Mark Lathrop, Tomi Pastinen, Pierre Bougnères

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Recombinant human growth hormone (rhGH) has shown a great growth-promoting potential in children with idiopathic short stature (ISS). However, the response to rhGH differs across individuals, largely due to genetic and epigenetic heterogeneity. Since epigenetic marks on the methylome can be dynamically influenced by GH, we performed a comprehensive pharmacoepigenomics analysis of DNA methylation changes associated with long-term rhGH administration in children with ISS.

RESULTS: We measured DNA methylation profiles before and after GH treatment (with a duration of ~ 18 months in average) on 47 healthy children using customized methylC-seq capture sequencing. Their changes were compared and associated …

Variation In Ampicillin Dosing For Lower Respiratory Tract Infections And Neonatal Bacterial Infections In Us Children's Hospitals., Elizabeth A. Daniels, Christopher C. Mcpherson, Jason G. Newland, Brian R. Lee

Manuscripts, Articles, Book Chapters and Other Papers

OBJECTIVE: We examined ampicillin dosing in pediatric patients across 3 conditions: (1) bacterial lower respiratory tract infections (LRTIs) in infants and children >3 months, (2) neonates with suspected or proven sepsis, and (3) neonates with suspected central nervous system (CNS) infections. We compared our findings to dosing guidance for these specific indications.

DESIGN: Retrospective cohort study.

SETTING: The study included data from 32 children's hospitals in the United States.

METHODS: We reviewed prescriptions from the SHARPS study of antimicrobials, a survey of antibiotic prescribing from July 2016 to December 2017. Prescriptions were analyzed for indication, total daily dose per kilogram, …

Strategies To Prevent Central Line-Associated Bloodstream Infections In Acute-Care Hospitals: 2022 Update., Niccolò Buetti, Jonas Marschall, Marci Drees, Mohamad G. Fakih, Lynn Hadaway, Lisa L. Maragakis, Elizabeth Monsees, Shannon Novosad, Naomi P. O'Grady, Mark E. Rupp, Joshua Wolf, Deborah Yokoe, Leonard A. Mermel

Manuscripts, Articles, Book Chapters and Other Papers

No abstract provided.

Cyp2d6 Gene Resequencing In The Malagasy, A Population At The Crossroads Between Asia And Africa: A Pilot Study, E Ricky Chan, Rajeev K. Mehlotra, Karim A Pirani, Arsene C. Ratsimbasoa, Scott M. Williams, Andrea Gaedigk, Peter A. Zimmerman

Manuscripts, Articles, Book Chapters and Other Papers

Background: Plasmodium vivax malaria is endemic in Madagascar, where populations have genetic inheritance from Southeast Asia and East Africa. Primaquine, a drug of choice for vivax malaria, is metabolized principally via CYP2D6. CYP2D6 variation was characterized by locus-specific gene sequencing and was compared with TaqMan™ genotype data. Materials & methods: Long-range PCR amplicons were generated from 96 Malagasy samples and subjected to next-generation sequencing. Results: The authors observed high concordance between TaqMan™-based CYP2D6 genotype calls and the base calls from sequencing. In addition, there are new variants and haplotypes present in the Malagasy. Conclusion: Sequencing unique admixed populations provides more …

Standardized Health Data And Research Exchange (Share): Promoting A Learning Health System., Sierra Davis, Louis Ehwerhemuepha, William Feaster, Jeffrey Hackman, Hiroki Morizono, Saravanan Kanakasabai, Abu Saleh Mohammad Mosa, Jerry Parker, Gary Iwamoto, Nisha Patel, Gary Gasparino, Natalie Kane, Mark A. Hoffman

Manuscripts, Articles, Book Chapters and Other Papers

Aggregate de-identified data from electronic health records (EHRs) provide a valuable resource for research. The Standardized Health data and Research Exchange (SHaRE) is a diverse group of US healthcare organizations contributing to the Cerner Health Facts (HF) and Cerner Real-World Data (CRWD) initiatives. The 51 facilities at the 7 founding organizations have provided data about more than 4.8 million patients with 63 million encounters to HF and 7.4 million patients and 119 million encounters to CRWD. SHaRE organizations unmask their organization IDs and provide 3-digit zip code (zip3) data to support epidemiology and disparity research. SHaRE enables communication between members, …

Moving The Needle Toward Fair Compensation In Pediatric Nephrology., Darcy K. Weidemann, I A Ashoor, D E Soranno, R Sheth, C Carter, P D Brophy

Manuscripts, Articles, Book Chapters and Other Papers

Remuneration issues are a substantial threat to the long-term stability of the pediatric nephrology workforce. It is uncertain whether the pediatric nephrology workforce will meet the growing needs of children with kidney disease without a substantial overhaul of the current reimbursement policies. In contrast to adult nephrology, the majority of pediatric nephrologists practice in an academic setting affiliated with a university and/or children's hospital. The pediatric nephrology service line is crucial to maintaining the financial health and wellness of a comprehensive children's hospital. However, in the current fee-for-service system, the clinical care for children with kidney disease is neither sufficiently …

Influenza Clinical Testing And Oseltamivir Treatment In Hospitalized Children With Acute Respiratory Illness, 2015-2016., Lubna Hamdan, Varvara Probst, Zaid Haddadin, Herdi Rahman, Andrew J. Spieker, Simon Vandekar, Laura S. Stewart, John V. Williams, Julie A. Boom, Flor Munoz, Janet A. Englund, Rangaraj Selvarangan, Mary A. Staat, Geoffrey A. Weinberg, Parvin H. Azimi, Eileen J. Klein, Monica Mcneal, Leila C. Sahni, Monica N. Singer, Peter G. Szilagyi, Christopher J. Harrison, Manish Patel, Angela P. Campbell, Natasha B. Halasa

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Antiviral treatment is recommended for all hospitalized children with suspected or confirmed influenza, regardless of their risk profile. Few data exist on adherence to these recommendations, so we sought to determine factors associated with influenza testing and antiviral treatment in children.

METHODS: Hospitalized children(ARI) were enrolled through active surveillance at pediatric medical centers in seven cities between 11/1/2015 and 6/30/2016; clinical information was obtained from parent interview and chart review. We used generalized linear mixed-effects models to identify factors associated with influenza testing and antiviral treatment.

RESULTS: Of the 2299 hospitalized children with ARI enrolled during one influenza season, …

Neutralizing Enterovirus D68 Antibodies In Children After 2014 Outbreak, Kansas City, Missouri, Usa., Robyn A. Livingston, Christopher J. Harrison, Rangaraj Selvarangan

Manuscripts, Articles, Book Chapters and Other Papers

Enterovirus D68 (EV-D68) causes severe respiratory illness outbreaks among children, particularly those with asthma. We previously detected neutralizing antibodies against the predominant EV-D68 B1 clade in the 2014 outbreak in serum collected before the outbreak (2012–2013) from persons 24 months to 85 years of age. We recently detected neutralizing antibodies to the 2014 B1, B2, and D clade viruses in serum collected after the 2014 outbreak (April–May 2017) from 300 children 6 months to 18 years of age. B1 virus neutralizing antibodies were found in 100% of patients, even children born after 2014; B2 in 84.6%, and D in 99.6%. …

Effectiveness Of Maternal Vaccination With Mrna Covid-19 Vaccine During Pregnancy Against Covid-19-Associated Hospitalization In Infants Aged <6 Months - 17 States, July 2021-January 2022., Natasha B. Halasa, Samantha M. Olson, Mary A. Staat, Margaret M. Newhams, Ashley M. Price, Julie A. Boom, Leila C. Sahni, Melissa A. Cameron, Pia S. Pannaraj, Katherine E. Bline, Samina S. Bhumbra, Tamara T. Bradford, Kathleen Chiotos, Bria M. Coates, Melissa L. Cullimore, Natalie Z. Cvijanovich, Heidi R. Flori, Shira J. Gertz, Sabrina M. Heidemann, Charlotte V. Hobbs, Janet R. Hume, Katherine Irby, Satoshi Kamidani, Michele Kong, Emily R. Levy, Elizabeth H. Mack, Aline B. Maddux, Kelly N. Michelson, Ryan A. Nofziger, Jennifer E. Schuster, Stephanie P. Schwartz, Laura Smallcomb, Keiko M. Tarquinio, Tracie C. Walker, Matt S. Zinter, Suzanne M. Gilboa, Kara N. Polen, Angela P. Campbell, Adrienne G. Randolph, Manish M. Patel, Overcoming Covid-19 Investigators, Overcoming Covid-19 Network

Manuscripts, Articles, Book Chapters and Other Papers

COVID-19 vaccination is recommended for persons who are pregnant, breastfeeding, trying to get pregnant now, or who might become pregnant in the future, to protect them from COVID-19.§ Infants are at risk for life-threatening complications from COVID-19, including acute respiratory failure (1). Evidence from other vaccine-preventable diseases suggests that maternal immunization can provide protection to infants, especially during the high-risk first 6 months of life, through passive transplacental antibody transfer (2). Recent studies of COVID-19 vaccination during pregnancy suggest the possibility of transplacental transfer of SARS-CoV-2-specific antibodies that might provide protection to infants (3-5); however, no epidemiologic evidence currently exists …

Coronavirus Disease 2019 (Covid-19) Research Agenda For Healthcare Epidemiology., Lona Mody, Ibukunoluwa C. Akinboyo, Hilary M. Babcock, Werner E. Bischoff, Vincent Chi-Chung Cheng, Kathleen Chiotos, Kimberly C. Claeys, K C Coffey, Daniel J. Diekema, Curtis J. Donskey, Katherine D. Ellingson, Heather M. Gilmartin, Shruti K. Gohil, Anthony D. Harris, Sara C. Keller, Eili Y. Klein, Sarah L. Krein, Jennie H. Kwon, Adam S. Lauring, Daniel J. Livorsi, Eric T. Lofgren, Katreena Merrill, Aaron M. Milstone, Elizabeth Monsees, Daniel J. Morgan, Luci P. Perri, Christopher D. Pfeiffer, Clare Rock, Sanjay Saint, Emily Sickbert-Bennett, Felicia Skelton, Katie J. Suda, Thomas R. Talbot, Valerie M. Vaughn, David J. Weber, Timothy L. Wiemken, Mohamed H. Yassin, Matthew J. Ziegler, Deverick J. Anderson, Shea Research Committee

Manuscripts, Articles, Book Chapters and Other Papers

This SHEA white paper identifies knowledge gaps and challenges in healthcare epidemiology research related to coronavirus disease 2019 (COVID-19) with a focus on core principles of healthcare epidemiology. These gaps, revealed during the worst phases of the COVID-19 pandemic, are described in 10 sections: epidemiology, outbreak investigation, surveillance, isolation precaution practices, personal protective equipment (PPE), environmental contamination and disinfection, drug and supply shortages, antimicrobial stewardship, healthcare personnel (HCP) occupational safety, and return to work policies. Each section highlights three critical healthcare epidemiology research questions with detailed description provided in supplementary materials. This research agenda calls for translational studies from laboratory-based …

Clinical Influenza Testing Practices In Hospitalized Children At United States Medical Centers, 2015-2018., Mark W. Tenforde, Angela P. Campbell, Marian G. Michaels, Christopher J. Harrison, Eileen J. Klein, Janet A. Englund, Rangaraj Selvarangan, Natasha B. Halasa, Laura S. Stewart, Geoffrey A. Weinberg, John V. Williams, Peter G. Szilagyi, Mary A. Staat, Julie A. Boom, Leila C. Sahni, Monica N. Singer, Parvin H. Azimi, Richard K. Zimmerman, Monica M. Mcneal, H Keipp Talbot, Arnold S. Monto, Emily T. Martin, Manjusha Gaglani, Fernanda P. Silveira, Donald B. Middleton, Jill M. Ferdinands, Melissa A. Rolfes

Manuscripts, Articles, Book Chapters and Other Papers

At nine US hospitals that enrolled children hospitalized with acute respiratory illness (ARI) during 2015-2016 through 2017-2018 influenza seasons, 50% of children with ARI received clinician-initiated testing for influenza and 35% of cases went undiagnosed due to lack of clinician-initiated testing. Marked heterogeneity in testing practice was observed across sites.

Simulation-Based System Analysis: Testing Preparedness For Extracorporeal Membrane Oxygenation Cannulation In Pediatric Covid-19 Patients., Alyssa Stoner, Robert Schremmer, Mikaela A. Miller, Kari L. Davidson, Rachael L. Pedigo, Jamie S. Parson, Christopher S. Kennedy, Eugenia K. Pallotto, Jenna Miller

Manuscripts, Articles, Book Chapters and Other Papers

Introduction: Coronavirus Disease-2019 presents risk to both patients and medical teams. Staff-intensive, complex procedures such as extracorporeal membrane oxygenation (ECMO) or extracorporeal cardiopulmonary resuscitation (eCPR) may increase chances of exposure and spread. This investigation aimed to rapidly deploy an in situ Simulation-based Clinical Systems Testing (SbCST) framework to identify Latent Safety Threats (LSTs) related to ECMO/eCPR initiation during a pandemic.

Methods: The adapted SbCST framework tested systems related to ECMO/eCPR initiation in the Neonatal and Pediatric Intensive Care Units. Systems were evaluated in six domains (Resources, Processes/Systems, Facilities, Clinical Performance, Infection Control, and Communication). We conducted three high-fidelity simulations with …

Effectiveness Of Bnt162b2 (Pfizer-Biontech) Mrna Vaccination Against Multisystem Inflammatory Syndrome In Children Among Persons Aged 12-18 Years - United States, July-December 2021., Laura D. Zambrano, Margaret M. Newhams, Samantha M. Olson, Natasha B. Halasa, Ashley M. Price, Julie A. Boom, Leila C. Sahni, Satoshi Kamidani, Keiko M. Tarquinio, Aline B. Maddux, Sabrina M. Heidemann, Samina S. Bhumbra, Katherine E. Bline, Ryan A. Nofziger, Charlotte V. Hobbs, Tamara T. Bradford, Natalie Z. Cvijanovich, Katherine Irby, Elizabeth H. Mack, Melissa L. Cullimore, Pia S. Pannaraj, Michele Kong, Tracie C. Walker, Shira J. Gertz, Kelly N. Michelson, Melissa A. Cameron, Kathleen Chiotos, Mia Maamari, Jennifer E. Schuster, Amber O. Orzel, Manish M. Patel, Angela P. Campbell, Adrienne G. Randolph, Overcoming Covid-19 Investigators

Manuscripts, Articles, Book Chapters and Other Papers

Multisystem inflammatory syndrome in children (MIS-C) is a severe postinfectious hyperinflammatory condition, which generally occurs 2-6 weeks after a typically mild or asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19 (1-3). In the United States, the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine is currently authorized for use in children and adolescents aged 5-15 years under an Emergency Use Authorization and is fully licensed by the Food and Drug Administration for persons aged ≥16 years (4). Prelicensure randomized trials in persons aged ≥5 years documented high vaccine efficacy and immunogenicity (5),§ and real-world studies in persons aged 12-18 years demonstrated high vaccine …

Ten Years Of Experience Support Pharmacogenetic Testing To Guide Individualized Drug Therapy., María Celsa Peña-Martín, Belén García-Berrocal, Almudena Sánchez-Martín, Elena Marcos-Vadillo, María Jesús García-Salgado, Santiago Sánchez, Carolina Lorenzo, David González-Parra, Francisco Sans, Manuel Franco, Andrea Gaedigk, María José Mateos-Sexmero, Catalina Sanz, María Isidoro-García

Manuscripts, Articles, Book Chapters and Other Papers

Precision medicine utilizing the genetic information of genes involved in the metabolism and disposition of drugs can not only improve drug efficacy but also prevent or minimize adverse events. Polypharmacy is common among multimorbid patients and is associated with increased adverse events. One of the main objectives in health care is safe and efficacious drug therapy, which is directly correlated to the individual response to treatment. Precision medicine can increase drug safety in many scenarios, including polypharmacy. In this report, we share our experience utilizing precision medicine over the past ten years. Based on our experience using pharmacogenetic (PGx)-informed prescribing, …

Whole-Genome Sequencing-Based Phylogeny, Antibiotic Resistance, And Invasive Phenotype Of Escherichia Coli Strains Colonizing The Cervix Of Women In Preterm Labor., Marvin Williams, Alyssa B. Jones, Amanda L. Maxedon, Jennifer E. Tabakh, Cindy B. Mccloskey, David E. Bard, Daniel P. Heruth, Susana Chavez-Bueno

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Escherichia coli is a major neonatal pathogen and the leading cause of early-onset sepsis in preterm newborns. Maternal E. coli strains are transmitted to the newborn causing invasive neonatal disease. However, there is a lack of data regarding the phenotypic and genotypic characterization of E. coli strains colonizing pregnant women during labor.

METHODS: This prospective study performed at the University of Oklahoma Medical Center (OUHSC) from March 2014 to December 2015, aimed to investigate the colonization rate, and the phylogeny, antibiotic resistance traits, and invasive properties of E. coli strains colonizing the cervix of fifty pregnant women diagnosed with …

Inter-Rater Reliability Of The Neonatal Adverse Event Severity Scale Using Real-World Neonatal Clinical Trial Data., Tamorah R. Lewis, Norma Terrin, Jonathan Davis, Kurt Michels, Thomas Salaets, Kelly Wade, International Neonatal Consortium

Manuscripts, Articles, Book Chapters and Other Papers

OBJECTIVE: The Neonatal Adverse Event Severity Scale (NAESS) was developed to improve scoring of neonatal adverse events (AEs) and accelerate neonatal drug development. This is the first validation study of the novel tool.

STUDY DESIGN: Retrospective validation study assessing the inter-rater reliability (IRR) of the NAESS. Reviewers used real-world AE data from a neonatal trial. Intra-class correlation (ICC) statistical analysis was performed.

RESULT: Sixty AEs were randomly assigned to twelve reviewers for a total of 240 severity scores. Generic and AE-specific NAESS tables were assessed. The ICC was 0.63 (95% confidence interval 0.51 to 0.73). Percent variation due to reviewer …

Multiplex Pcr Pathogen Detection In Acute Gastroenteritis Among Hospitalized Us Children Compared With Healthy Controls During 2011-2016 In The Post-Rotavirus Vaccine Era., Christopher J. Harrison, Ferdaus Hassan, Brian R. Lee, Julie Boom, Leila C. Sahni, Coreen Johnson, James Dunn, Daniel C. Payne, Mary E. Wikswo, Umesh Parashar, Rangaraj Selvarangan

Manuscripts, Articles, Book Chapters and Other Papers

Background: Despite vaccine-induced decreases in US rotavirus (RV) disease, acute gastroenteritis (AGE) remains relatively common. We evaluated AGE pathogen distribution in hospitalized US children in the post-RV vaccine era.

Methods: From December 2011 to June 2016, the New Vaccine Surveillance Network (NVSN) conducted prospective, active, population-based surveillance in hospitalized children with AGE. We tested stools from 2 NVSN sites (Kansas City, Houston) with Luminex x-TAG Gastrointestinal Pathogen Panels (Luminex GPP) and analyzed selected signs and symptoms.

Results: For 660 pediatric AGE inpatients and 624 age-matched healthy controls (HCs), overall organism detection was 51.2% and 20.6%, respectively (P < .001). Among AGE subjects, GPP polymerase chain reaction detected >1 virus …

Enterovirus D68-Associated Acute Respiratory Illness ─ New Vaccine Surveillance Network, United States, July-November 2018-2020., Melisa M. Shah, Ariana Perez, Joana Y. Lively, Vasanthi Avadhanula, Julie A. Boom, James Chappell, Janet A. Englund, Wende Fregoe, Natasha B. Halasa, Christopher J. Harrison, Robert W. Hickey, Eileen J. Klein, Monica M. Mcneal, Marian G. Michaels, Mary Moffatt, Catherine Otten, Leila C. Sahni, Elizabeth Schlaudecker, Jennifer E. Schuster, Rangaraj Selvarangan, Mary A. Staat, Laura S. Stewart, Geoffrey A. Weinberg, John V. Williams, Terry Fan Fei Ng, Janell A. Routh, Susan I. Gerber, Meredith L. Mcmorrow, Brian Rha, Claire M. Midgley

Manuscripts, Articles, Book Chapters and Other Papers

Enterovirus D68 (EV-D68) is associated with a broad spectrum of illnesses, including mild to severe acute respiratory illness (ARI) and acute flaccid myelitis (AFM). Enteroviruses, including EV-D68, are typically detected in the United States during late summer through fall, with year-to-year fluctuations. Before 2014, EV-D68 was infrequently reported to CDC (1). However, numbers of EV-D68 detection have increased in recent years, with a biennial pattern observed during 2014-2018 in the United States, after the expansion of surveillance and wider availability of molecular testing. In 2014, a national outbreak of EV-D68 was detected (2). EV-D68 was also reported in 2016 via …

Rotavirus Genotype Trends And Gastrointestinal Pathogen Detection In The United States, 2014-2016: Results From The New Vaccine Surveillance Network., Mathew D. Esona, M Leanne Ward, Mary E. Wikswo, Slavica M. Rustempasic, Rashi Gautam, Charity Perkins, Rangaraj Selvarangan, Christopher J. Harrison, Julie A. Boom, Janet A. Englund, Eileen J. Klein, Mary Allen Staat, Monica M. Mcneal, Natasha Halasa, James Chappell, Geoffrey A. Weinberg, Daniel C. Payne, Umesh D. Parashar, Michael D. Bowen

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Following the implementation of rotavirus vaccination in 2006, severe acute gastroenteritis (AGE) due to group A rotavirus (RVA) has substantially declined in US children. We report the RVA genotype prevalence as well as coinfection data from 7 US New Vaccine Surveillance Network sites during 3 consecutive RVA seasons, 2014-2016.

METHODS: A total of 1041 stool samples that tested positive for RVA by Rotaclone enzyme immunoassay were submitted to the Centers for Disease Control and Prevention (CDC) for RVA genotyping and multipathogen testing.

RESULTS: A total of 795 (76%) samples contained detectable RVA when tested at the CDC. Rotavirus disease …

A Call To Action: Issuing A Diversity And Inclusion Challenge To Research Organizations., Susan M. Abdel-Rahman, Michelle P. Wimes, Tom Curran

Manuscripts, Articles, Book Chapters and Other Papers

Individuals who identify as Black, indigenous, and people of color face well-documented health disparities. A root cause is the lack of empiric evidence for or against the use of various treatments in their medical management. This communication proposes a new benchmarking strategy for evaluating racial and ethnic representation in clinical research that can be compared across institutions with the intent of increasing accountability for diversity and inclusion among organizations that conduct clinical research.

Healthcare System-To-System Cost Variability In The Care Of Pediatric Abdominal Pain-Associated Functional Gastrointestinal Disorders., Michelle Livitz, Alec S. Friesen, Earl F. Glynn, Jennifer Verrill Schurman, Jennifer Colombo, Craig A. Friesen

Manuscripts, Articles, Book Chapters and Other Papers

The purpose of this study was to assess cost variability in the care of abdominal pain-associated functional gastrointestinal disorders (AP-FGIDS) in youth across health systems, races, and specific AP-FGID diagnoses. Patients, aged 8-17 years, with a priority 1 diagnosis corresponding to a Rome IV defined AP-FGID were identified within the Health Facts® database. Total costs were obtained across the continuum of care including outpatient clinics, emergency department, and inpatient or observation units. Cost variability was described comparing different health systems, races, and diagnoses. Thirteen thousand two hundred and fourteen patients were identified accounting for 17,287 encounters. Total costs were available …

Effectiveness Of Pfizer-Biontech Mrna Vaccination Against Covid-19 Hospitalization Among Persons Aged 12-18 Years - United States, June-September 2021., Samantha M. Olson, Margaret M. Newhams, Natasha B. Halasa, Ashley M. Price, Julie A. Boom, Leila C. Sahni, Katherine Irby, Tracie C. Walker, Stephanie P. Schwartz, Pia S. Pannaraj, Aline B. Maddux, Tamara T. Bradford, Ryan A. Nofziger, Benjamin J. Boutselis, Melissa L. Cullimore, Elizabeth H. Mack, Jennifer E. Schuster, Shira J. Gertz, Natalie Z. Cvijanovich, Michele Kong, Melissa A. Cameron, Mary A. Staat, Emily R. Levy, Brandon M. Chatani, Kathleen Chiotos, Laura D. Zambrano, Angela P. Campbell, Manish M. Patel, Adrienne G. Randolph, Overcoming Covid-19 Investigators

Manuscripts, Articles, Book Chapters and Other Papers

Pfizer-BioNTech COVID-19 vaccine is authorized for use in children and adolescents aged 12-15 years and is licensed by the Food and Drug Administration (FDA) for persons aged ≥16 (1). A randomized placebo-controlled trial demonstrated an efficacy of 100% (95% confidence interval [CI] = 75.3%-100%) in preventing outpatient COVID-19 in persons aged 12-15 years (2); however, data among adolescents on vaccine effectiveness (VE) against COVID-19 in real-world settings are limited, especially among hospitalized patients. In early September 2021, U.S. pediatric COVID-19 hospitalizations reached the highest level during the pandemic (3,4). In a test-negative, case-control study at 19 pediatric hospitals in 16 …