82 results on '"Nesin M"'
Search Results
2. Neurodevelopmental delay: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data
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Villagomez, A.N. (Adrienne N.), Muñoz, F.M. (Flor M.), Peterson, R.L. (Robin L.), Colbert, A.M. (Alison M.), Gladstone, M. (Melissa), MacDonald, B. (Beatriz), Wilson, R. (Rebecca), Fairlie, L. (Lee), Gerner, G.J. (Gwendolyn J.), Patterson, J. (Jackie), Boghossian, N.S. (Nansi S.), Burton, V.J. (Vera Joanna), Cortés, M. (Margarita), Katikaneni, L.D. (Lakshmi D.), Larson, J.C.G. (Jennifer C.G.), Angulo, A.S. (Abigail S.), Joshi, J. (Jyoti), Nesin, M. (Mirjana), Padula, M.A. (Michael A.), Kochhar, S. (Sonali), Connery, A.K. (Amy K.), Villagomez, A.N. (Adrienne N.), Muñoz, F.M. (Flor M.), Peterson, R.L. (Robin L.), Colbert, A.M. (Alison M.), Gladstone, M. (Melissa), MacDonald, B. (Beatriz), Wilson, R. (Rebecca), Fairlie, L. (Lee), Gerner, G.J. (Gwendolyn J.), Patterson, J. (Jackie), Boghossian, N.S. (Nansi S.), Burton, V.J. (Vera Joanna), Cortés, M. (Margarita), Katikaneni, L.D. (Lakshmi D.), Larson, J.C.G. (Jennifer C.G.), Angulo, A.S. (Abigail S.), Joshi, J. (Jyoti), Nesin, M. (Mirjana), Padula, M.A. (Michael A.), Kochhar, S. (Sonali), and Connery, A.K. (Amy K.)
- Published
- 2019
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3. Congenital microcephaly: Case definition & guidelines for data collection, analysis, and presentation of safety data after maternal immunisation
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DeSilva, M, Munoz, FM, Sell, E, Marshall, H, Tse Kawai, A, Kachikis, A, Heath, P, Klein, NP, Oleske, JM, Jehan, F, Spiegel, H, Nesin, M, Tagbo, BN, Shrestha, A, Cutland, CL, Eckert, LO, Kochhar, S, Bardají, A, and Brighton Collaboration Congenital Microcephaly Working Group
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Malalties hereditàries ,Malalties cerebrals ,Brain diseases ,Genetic diseases - Abstract
Need for developing case definitions and guidelines for data collection, analysis, and presentation for congenital microcephaly as an adverse event following maternal immunisation Congenital microcephaly, also referred to as primary microcephaly due to its presence in utero or at birth, is a descriptive term for a structural defect in which a fetus or infant’s head (cranium) circumference is smaller than expected when compared to other fetuses or infants of the same gestational age, sex and ethnic background.
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- 2017
4. Congenital microcephaly: Case definition & guidelines for data collection, analysis, and presentation of safety data after maternal immunisation
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DeSilva, M. (Malini), Munoz, F.M. (Flor M.), Sell, E. (Erick), Marshall, H. (Helen), Tse Kawai, A. (Alison), Kachikis, A. (Alisa), Heath, P. (Paul), Klein, N.P. (Nicola P.), Oleske, J.M. (James M.), Jehan, F. (Fyezah), Spiegel, H. (Hans), Nesin, M. (Mirjana), Tagbo, B.N. (Beckie N.), Shrestha, A. (Anju), Cutland, C.L. (Clare L.), Eckert, L.O. (Linda O.), ), Bardají, A. (Azucena), DeSilva, M. (Malini), Munoz, F.M. (Flor M.), Sell, E. (Erick), Marshall, H. (Helen), Tse Kawai, A. (Alison), Kachikis, A. (Alisa), Heath, P. (Paul), Klein, N.P. (Nicola P.), Oleske, J.M. (James M.), Jehan, F. (Fyezah), Spiegel, H. (Hans), Nesin, M. (Mirjana), Tagbo, B.N. (Beckie N.), Shrestha, A. (Anju), Cutland, C.L. (Clare L.), Eckert, L.O. (Linda O.), ), and Bardají, A. (Azucena)
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- 2017
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5. Small for gestational age: Case definition & guidelines for data collection, analysis, and presentation of maternal immunisation safety data
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Schlaudecker, E.P. (Elizabeth P.), Munoz, F.M. (Flor M.), Bardají, A. (Azucena), Boghossian, N.S. (Nansi S.), Khalil, A. (Asma), Mousa, H. (Hatem), Nesin, M. (Mirjana), Nisar, M.I. (Muhammad Imran), Pool, V. (Vitali), Spiegel, H.M.L. (Hans M.L.), Tapia, M.D. (Milagritos D.), Kochhar, S. (Sonali), Black, S. (Steve), Schlaudecker, E.P. (Elizabeth P.), Munoz, F.M. (Flor M.), Bardají, A. (Azucena), Boghossian, N.S. (Nansi S.), Khalil, A. (Asma), Mousa, H. (Hatem), Nesin, M. (Mirjana), Nisar, M.I. (Muhammad Imran), Pool, V. (Vitali), Spiegel, H.M.L. (Hans M.L.), Tapia, M.D. (Milagritos D.), Kochhar, S. (Sonali), and Black, S. (Steve)
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- 2017
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6. Small for gestational age: Case definition & guidelines for data collection, analysis, and presentation of maternal immunisation safety data
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Schlaudecker, EP, Munoz, F M, Bardaji, Azucena, Boghossian, NS, Khalil, A, Mousa, H, Nesin, M, Nisar, MI, Pool, V, Spiegel, HML, Tapia, MD, Kochhar, Sonali, Black, S, Schlaudecker, EP, Munoz, F M, Bardaji, Azucena, Boghossian, NS, Khalil, A, Mousa, H, Nesin, M, Nisar, MI, Pool, V, Spiegel, HML, Tapia, MD, Kochhar, Sonali, and Black, S
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- 2017
7. NOVGOROD TYSYATSKIYE IN 1410-1420-IES
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Nesin, M. A., primary
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- 2016
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8. Urinary level of vitamin D-binding protein as a new biomarker for diabetic nephropathy
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Nesin M Kotb, Kamal A Ahmed, Samy A Khodeir, Kamal M Okasha, and Hala M Nagy
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medicine.medical_specialty ,Kidney ,business.industry ,Vitamin D-binding protein ,Urinary system ,Type 2 Diabetes Mellitus ,medicine.disease ,Gastroenterology ,Diabetic nephropathy ,medicine.anatomical_structure ,Endocrinology ,Internal medicine ,Diabetes mellitus ,Vitamin D and neurology ,Medicine ,Biomarker (medicine) ,business - Abstract
Diabetes is now the major cause of end-stage kidney failure, both in developing and developed nations. It is the primary diagnosis causing kidney diseases in 20-40% of patients starting treatment for end-stage renal diseases worldwide. The aim of the study was to evaluate the urinary level of vitamin D-binding protein (UVDBP) as a new biomarker for diabetic nephropathy (DN). Urine samples were obtained from 45 patients with type 2 diabetes mellitus and were classified into three groups (normoalbuminuric, microalbuminuric, and macroalbuminuric). Fifteen healthy participants served as the control group. The excretion levels of UVDBP were quantified with enzyme-linked immunosorbent assay. The results showed that UVDBP levels were significantly elevated in patients of the DN3 and DN4 groups compared with those of the DN2 group and normal controls. In conclusion, the current study demonstrated that UVDBP levels were significantly elevated in patients with DN. Moreover, a strong positive correlation was observed between the expression level of UVDBP and the development of DN. Thus, the findings indicate that UVDBP levels are a potential biomarker for the early detection of DN.
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- 2016
9. Staphylococcal vaccines and immunotherapy: to dream the impossible dream?
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PROJAN, S, primary, NESIN, M, additional, and DUNMAN, P, additional
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- 2006
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10. Introduction of complementary foods in preterm infants varies amongcountries
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Yee, J., primary, Smith, A.M., additional, O'Connor, D.L., additional, Auestad, N., additional, Adamkin, D., additional, Connor, W.E., additional, Connor, S.L., additional, Groh-Wargo, S., additional, Hall, R., additional, Lucas, A., additional, Mena, P., additional, Nesin, M., additional, Singer, L., additional, Stephenson, T., additional, and Szabo, J., additional
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- 2001
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11. Randomized Trial of Premature Infants Fed Human Milk and/or a Nutrient Enriched Formula with and without a Source of Arachidonic Acid (AA) and DocosahexaenoicAcid (DHA)
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O'Connor, D L, primary, Hall, R T, additional, Adamkin, D, additional, Connor, W, additional, Lucas, A, additional, Groh-Wargo, S, additional, Mena, P, additional, Nesin, M, additional, Singer, L, additional, Szabo, J, additional, Jacobs, J, additional, Qiu, W, additional, Tressler, R L, additional, and Auestad, N, additional
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- 1999
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12. Growth, Tolerance, and Morbidity of Preterm Infants Fed Exclusively Human Milk, Exclusively Preterm Infant Formula, or a Combination of Human Milk and a Preterm Infant Formula until Term Corrected Age (CA)
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O'Connor, D L, primary, Hall, R T, additional, Adamkin, D, additional, Connor, W, additional, Lucas, A, additional, Groh-Wargo, S, additional, Mena, P, additional, Nesin, M, additional, Singer, L, additional, Szabo, J, additional, Jacobs, J, additional, Qiu, W, additional, Tressler, R L, additional, and Auestad, N, additional
- Published
- 1999
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13. Review of the Monograph: Seleznev Yu.V. Russkie knyaz’ya pri dvore khanov Zolotoy Ordy (Russian Princes at the Court of the Golden Horde Khans)
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Nesin M.A.
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Auxiliary sciences of history ,History of Civilization ,CB3-482 - Abstract
This article contains a review of the monograph by Yu.V. Seleznev published in early 2017 and dedicated to the relations of Russian princes with the Golden Horde’s khans and their status among the Golden Horde’s nobility. This work is the first comprehensive study in the historiography of this issue for all two and a half centuries of the Tartar domination. The monograph was published for the first time in 2013 and served as the basis for a doctoral dissertation, which Seleznev defended in 2015. The book was reprinted with certain changes in 2017. The book commendably contains an abundance of factual material through the use of diverse sources and strands of historiography. Seleznev examines the social terminology of Golden Horde-Russian relations, the structure of the Golden Horde’s nobility and the trips of princes to the Horde, drawing attention not only to the status of the great Vladimir and Moscow princes, but also that of other great and appanage princes. He makes a significant contribution to the resolving the debate regarding the nature of the Golden Horde’s domination in Rus’ by examining in detail the relationship of the Russian princes with the Golden Horde’s authorities in different years. The book’s author proposed to divide the Golden Horde’s “yoke” into seven periods characterized by “changes in the degree of sovereignty and jurisdiction of the khan in relation to Russian principalities”. The author of this review agrees with the main conclusions of the book under review, but at the same time he notes some reservations and criticisms, which do not, however, reduce the academic caliber of the monograph.
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- 2017
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14. Molecular epidemiology of Staphylococcus epidermidis blood isolates from neonatal intensive care unit patients
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Nesin, M., primary, Projan, S.J., additional, Kreiswirth, B., additional, Bolt, Y., additional, and Novick, R.P., additional
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- 1995
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15. Cloning and nucleotide sequence of a chromosomally encoded tetracycline resistance determinant, tetA(M), from a pathogenic, methicillin-resistant strain of Staphylococcus aureus
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Nesin, M, primary, Svec, P, additional, Lupski, J R, additional, Godson, G N, additional, Kreiswirth, B, additional, Kornblum, J, additional, and Projan, S J, additional
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- 1990
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16. Gram-negative bacilli associated with catheter-associated and non-catheter-associated bloodstream infections and hand carriage by healthcare workers in neonatal intensive care units.
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Larson EL, Cimiotti JP, Haas J, Nesin M, Allen A, Della-Latta P, Saiman L, Larson, Elaine L, Cimiotti, Jeannie P, Haas, Janet, Nesin, Mirjana, Allen, Ari, Della-Latta, Phyllis, and Saiman, Lisa
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- 2005
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17. Effect of antiseptic handwashing vs alcohol sanitizer on health care-associated infections in neonatal intensive care units.
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Larson EL, Cimiotti J, Haas J, Parides M, Nesin M, Della-Latta P, and Saiman L
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- 2005
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18. Growth and development in preterm infants fed long-chain polyunsaturated fatty acids: a prospective, randomized controlled trial.
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O'Connor DL, Hall R, Adamkin D, Auestad N, Castillo M, Connor WE, Connor SL, Fitzgerald K, Groh-Wargo S, Hartmann EE, Jacobs J, Janowsky J, Lucas A, Margeson D, Mena P, Neuringer M, Nesin M, Singer L, Stephenson T, and Szabo J
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- 2001
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19. A randomized, double-blind, placebo-controlled trial of prophylactic recombinant human granulocyte-macrophage colony-stimulating factor to reduce nosocomial infections in very low birth weight neonates
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Cairo, M.S., Agosti, J., Ellis, R., Laver, J.J., Puppala, B., de Lemos, R., Givner, L., Nesin, M., Wheeler, J., Seth, T., van de Ven, C., and Fanaroff, A.
- Abstract
Objective: We carried out a randomized placebo-controlled trial in very low birth weight neonates (VLBWNs), comparing the incidence of nosocomial infections after the prophylactic use of recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) versus placebo in VLBWNs. Study design: VLBWNs (n = 264), weighing 501 to 1000 g, @?72 hours of age were randomly assigned to receive rhu GM-CSF (8 @mg/kg/d), administered intravenously (n = 134) over 2 hours daily x 7 days and every other day for 21 days, or placebo (n = 130). The safety, incidence of nosocomial infections, days of absolute neutrophil count >=4000/mm,^3 peripheral blood progenitor studies, and 24-hour polymorphonuclear leukocyte C3bi receptor expression were compared between the 2 treatment groups. Results: No (grade III/IV) toxicity or adverse events were associated with rhu GM-CSF. The absolute neutrophil count and absolute eosinophil count were significantly elevated in the rhu GM-CSF group on days 7 (P = .001), 14 (P = .001), and 21 (P = .007) and on days 7 and 28 (P = .012 and P = .001, respectively). However, there was no difference in the incidence of confirmed nosocomial infections between the 2 treatment groups in this trial (40% vs 39%, rhu GM-CSF vs placebo; P = NS). Conclusion: In a large randomized placebo-controlled trial, prophylactic administration of rhu GM-CSF in VLBWNs does not appear to decrease the incidence of nosocomial infections. (J Pediatr 1999;134:64-70)
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- 1999
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20. Role of the 5' upstream sequence and tandem promoters in regulation of the rpsU-dnaG-rpoD macromolecular synthesis operon
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Nesin, M, Lupski, J R, and Godson, G N
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Bal31 exonuclease deletion analysis and transposon Tn5 mutagenesis of the 5' regulatory region of the rpsU-dnaG-rpoD macromolecular synthesis operon fused to the chloramphenicol acetyltransferase gene (pGLR301) demonstrated that sequences 5' to the operon promoters were not involved in operon transcriptional regulation and that the three tandem promoters P1, P2, and P3 were functionally independent. P2 was the strongest promoter, and P3 was the weakest. P1, P2, and P3 acting in combination appeared to be stronger than the individual promoters.
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- 1988
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21. Emergence of Resistant Staphylococci on the Hands of New Graduate Nurses
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Cimiotti∗, J., Wu, F., Della-Latta, P., Nesin, M., and Larson, E.
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- 2004
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22. Capsular transformation of a multidrug-resistant Streptococcus pneumoniae in vivo
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Nesin, M., Ramirez, M., and Alexander Tomasz
23. Development of Next-Generation COVID-19 Vaccines: BARDA Supported Phase 2b Study Designs.
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Wolfe DN, Arangies E, David GL, Armstrong B, Scocca TZ, Fedler J, Natarajan R, Zhou J, Jayashankar L, Donis R, Nesin M, Meissner HC, Lemiale L, Kovacs GR, Rele S, Mason R, and Cao H
- Abstract
In response to the COVID-19 pandemic, vaccines were quickly and successfully developed and deployed, saving millions of lives globally. While first generation vaccines are safe and effective in preventing disease caused by SARSCoV-2, next-generation vaccines have the potential to improve efficacy and safety. Vaccines delivered by a mucosal route may elicit greater protective immunity at respiratory surfaces thereby reducing transmission. Inclusion of viral antigens in addition to the spike protein may enhance protection against emerging variants of concern. Next-generation vaccine platforms with a new mechanism of action may necessitate efficacy trials to fulfill regulatory requirements. The Biomedical Advanced Research and Development Authority (BARDA) will be supporting Phase 2b clinical trials of candidate next-generation vaccines. The primary endpoint will be improved efficacy in terms of symptomatic disease relative to a currently approved COVID-19 vaccine. In this paper, we discuss the planned endpoints and potential challenges to this complex program., (Published by Oxford University Press on behalf of Infectious Diseases Society of America 2024.)
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- 2024
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24. Duration of Cellular and Humoral Responses after Quadrivalent Human Papillomavirus Vaccination in Healthy Female Adults with or without Prior Type 16 and/or 18 Exposure.
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Lai L, Ault K, Rouphael N, Beck A, Domjahn B, Xu Y, Anderson EJ, Cheng A, Nakamura A, Hoagland RJ, Kelley C, Edupuganti S, Mask K, Nesin M, Unger ER, Panicker G, David H, and Mulligan MJ
- Abstract
Human papillomavirus virus (HPV) vaccines aim to provide durable protection and are ideal to study the association of cellular with humoral responses. We assessed the duration and characteristics of immune responses provided by the quadrivalent HPV (4vHPV) vaccine in healthy female adults with or without prior exposure with type 16 and 18 HPV. In a prospective cohort, vaccine naïve females received three doses of 4vHPV vaccine and were followed for two years to assess cellular (intracellular cytokine staining, proliferation and B cell ELISpot assays) and humoral (multiplex L1/L2 viral-like particles (VLP) and M4 ELISAs) responses. Frequencies of vaccine-specific CD4+ T cells correlated with antibody responses. Higher HPV antibody titers were found at all time points in participants previously exposed to HPV, except for anti-HPV-18 at Day 187 (one week post the third vaccination). Retrospective cohorts enrolled females who had previously received two or three 4vHPV doses and tested antibody titers by M4 ELISA and pseudovirion neutralization assay along with memory B cells (MBCs). Almost all women enrolled in a retrospective cohort with two prior doses and all women enrolled in a retrospective cohort with three prior doses had sustained antibody and memory responses. Our findings indicate that HPV vaccination induces a long-lasting, robust cellular and humoral immune responses.
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- 2020
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25. Small for gestational age: Case definition & guidelines for data collection, analysis, and presentation of maternal immunisation safety data.
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Schlaudecker EP, Munoz FM, Bardají A, Boghossian NS, Khalil A, Mousa H, Nesin M, Nisar MI, Pool V, Spiegel HML, Tapia MD, Kochhar S, and Black S
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- Female, Humans, Infant, Newborn, Pregnancy, Adverse Drug Reaction Reporting Systems standards, Data Collection standards, Epidemiologic Methods, Fetal Development, Gestational Age, Vaccination adverse effects
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- 2017
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26. Congenital microcephaly: Case definition & guidelines for data collection, analysis, and presentation of safety data after maternal immunisation.
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DeSilva M, Munoz FM, Sell E, Marshall H, Tse Kawai A, Kachikis A, Heath P, Klein NP, Oleske JM, Jehan F, Spiegel H, Nesin M, Tagbo BN, Shrestha A, Cutland CL, Eckert LO, Kochhar S, and Bardají A
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- Female, Humans, Pregnancy, Adverse Drug Reaction Reporting Systems standards, Data Collection standards, Epidemiologic Methods, Microcephaly epidemiology, Vaccination adverse effects
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- 2017
- Full Text
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27. Maternal immunization efforts of the National Institutes of Health.
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Rubin FA, Koso-Thomas M, Isaacs MB, Piper J, Read J, and Nesin M
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- Animals, Clinical Studies as Topic methods, Disease Models, Animal, Drug Discovery methods, Drug Discovery trends, Drug Evaluation, Preclinical methods, Female, Humans, Immunization statistics & numerical data, National Institutes of Health (U.S.), Pregnancy, Translational Research, Biomedical methods, Translational Research, Biomedical organization & administration, United States, Disease Transmission, Infectious prevention & control, Immunization methods, Pregnancy Complications, Infectious prevention & control, Vaccines administration & dosage, Vaccines immunology
- Abstract
Over the last 35 years, efforts at the National Institutes of Health (NIH) to protect mothers and their infants against infectious diseases have involved a bench-to-bedside approach. Basic and translational research that provided a foundation for clinical trials of vaccines in pregnancy include natural history and vaccine antigen identification studies. Development of laboratory assays and reagents have been funded by NIAID; these are critical for the advancement of vaccine candidates through the preclinical and clinical steps along the maternal immunization research pathway to support vaccine efficacy. Animal models of maternal immunization have been developed to evaluate efficacy of vaccine candidates. Clinical studies required development of maternal immunization protocols to address specific pregnancy related issues, for enrollment and safety assessment of mothers and their infants. NIH has organized and participated in meetings, workshops and other collaborative efforts with partners have advanced maternal immunization efforts. Partners have included many institutes and offices at NIH as well as other Department of Health and Human Services agencies and offices (Food and Drug Administration, Centers for Disease Control and Prevention, National Vaccine Program Office), World Health Organization, academic investigators, Biotech and pharmaceutical companies, and nonprofit organizations such as the Bill and Melinda Gates Foundation. These research and development partnership are essential for advancing maternal immunization. Continued efforts are needed to promote maternal immunization to protect pregnant women and their infants against vaccine-preventable infectious disease, especially in resource-limited settings where the burden of infections is high., (Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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- 2015
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28. Maternal Immunization: Current status and future prospects.
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Nesin M, Read J, Koso-Thomas M, Isaacs MB, and Meulen AS
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- Female, Humans, Immunization statistics & numerical data, Infant, Newborn, Pregnancy, Disease Transmission, Infectious prevention & control, Immunization methods, Pregnancy Complications, Infectious prevention & control, Vaccines administration & dosage, Vaccines immunology
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- 2015
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29. Vaccine monitoring systems: A potential model for medications in pregnancy.
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Nesin M and Sparer O
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- Adult, Adverse Drug Reaction Reporting Systems, Female, Humans, Influenza A Virus, H1N1 Subtype, Pregnancy, Pregnancy Complications, Infectious immunology, Product Surveillance, Postmarketing, United States epidemiology, Vaccination, Diphtheria-Tetanus-Pertussis Vaccine administration & dosage, Immunization Schedule, Infectious Disease Transmission, Vertical prevention & control, Influenza Vaccines administration & dosage, Influenza, Human prevention & control, Patient Compliance statistics & numerical data, Pregnancy Complications, Infectious prevention & control, Pregnant Women
- Abstract
Multiple vaccine safety systems contribute to monitor and assess the safety of vaccines given to pregnant women and their offspring. This article presents a review of the strengths and limitations of several national vaccine safety systems. The review concludes that the present framework of vaccine safety systems offers lessons to be learned toward the design of a system for monitoring and assessing the safety of medications administered to pregnant women in clinical practice and research., (Published by Elsevier Inc.)
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- 2015
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30. Assessment of safety in newborns of mothers participating in clinical trials of vaccines administered during pregnancy.
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Munoz FM, Weisman LE, Read JS, Siberry G, Kotloff K, Friedman J, Higgins RD, Hill H, Seifert H, and Nesin M
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- Female, Humans, Infant, Newborn, Mothers, Pregnancy, Pregnancy Outcome, United States, Vaccination, Clinical Trials as Topic, Pregnancy Complications, Infectious prevention & control, Vaccines administration & dosage, Vaccines adverse effects
- Abstract
A panel of experts convened by the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, developed proposed guidelines for the evaluation of adverse events in newborns of women participating in clinical trials of maternal immunization in the United States., (© The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)
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- 2014
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31. Designing drug trials: considerations for pregnant women.
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Sheffield JS, Siegel D, Mirochnick M, Heine RP, Nguyen C, Bergman KL, Savic RM, Long J, Dooley KE, and Nesin M
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- Adult, Female, Humans, Infant, Maternal-Fetal Exchange, Pharmacokinetics, Placenta physiology, Pregnancy, Pregnancy Outcome, Research Design, United States, United States Food and Drug Administration, Clinical Protocols, Clinical Trials as Topic, Pregnant Women
- Abstract
Clinical pharmacology studies that describe the pharmacokinetics and pharmacodynamics of drugs in pregnant women are critical for informing on the safe and effective use of drugs during pregnancy. That being said, multiple factors have hindered the ability to study drugs in pregnant patients. These include concerns for maternal and fetal safety, ethical considerations, the difficulty in designing appropriate trials to assess the study objectives, and funding limitations. This document summarizes the recommendations of a panel of experts convened by the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health. These experts were charged with reviewing the issues related to the development of preclinical and clinical drug studies in pregnant women and to develop strategies for addressing these issues. These findings may also be utilized in the development of future drug studies involving pregnant women and their fetus/neonate., (© The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)
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- 2014
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32. Assessment of congenital anomalies in infants born to pregnant women enrolled in clinical trials.
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Rasmussen SA, Hernandez-Diaz S, Abdul-Rahman OA, Sahin L, Petrie CR, Keppler-Noreuil KM, Frey SE, Mason RM, Nesin M, and Carey JC
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- Anti-Infective Agents administration & dosage, Female, Humans, Infant, Infant, Newborn, Pregnancy, United States, Vaccines administration & dosage, Clinical Trials as Topic, Congenital Abnormalities diagnosis, Congenital Abnormalities epidemiology, Pregnant Women
- Abstract
In 2011 and 2012, the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health, held a series of meetings to provide guidance to investigators regarding study design of clinical trials of vaccines and antimicrobial medications that enroll pregnant women. Assessment of congenital anomalies among infants born to women enrolled in these trials was recognized as a challenging issue, and a workgroup with expertise in epidemiology, pediatrics, genetics, dysmorphology, clinical trials, and infectious diseases was formed to address this issue. The workgroup considered 3 approaches for congenital anomalies assessment that have been developed for use in other studies: (1) maternal report combined with medical records review, (2) standardized photographic assessment and physical examination by a health professional who has received specific training in congenital anomalies, and (3) standardized physical examination by a trained dysmorphologist (combined with maternal interview and medical records review). The strengths and limitations of these approaches were discussed with regard to their use in clinical trials. None of the approaches was deemed appropriate for use in all clinical trials. Instead, the workgroup acknowledged that decisions regarding the optimal method of assessment of congenital anomalies will likely vary depending on the clinical trial, its setting, and the agent under study; in some cases, a combination of approaches may be appropriate. The workgroup recognized the need for more research on approaches to the assessment of congenital anomalies to better guide investigators in optimal design of clinical trials that enroll pregnant women., (Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.)
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- 2014
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33. Research on vaccines during pregnancy: reference values for vital signs and laboratory assessments.
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Sheffield JS, Munoz FM, Beigi RH, Rasmussen SA, Edwards KM, Read JS, Heine RP, Ault KA, Swamy GK, Jevaji I, Spong CY, Fortner KB, Patel SM, and Nesin M
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- Female, Humans, Infant, Newborn, Infant, Newborn, Diseases prevention & control, Pregnancy, Pregnancy Complications, Infectious prevention & control, Reference Values, Blood Chemical Analysis, Vaccination adverse effects, Vaccines adverse effects, Vaccines therapeutic use
- Abstract
The Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health organized a series of conferences, "Enrolling Pregnant Women in Clinical Trials of Vaccines and Therapeutics", to discuss enrollment and safety assessments of pregnant women in clinical trials of vaccines. Experts in obstetrics, maternal-fetal medicine, infectious diseases, pediatrics, neonatology, genetics, vaccinology and clinical trial design were charged with identifying normal ranges for vital signs and laboratory assessments in pregnancy. A grading system for adverse events was then developed., (Copyright © 2013 Elsevier Ltd. All rights reserved.)
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- 2013
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34. Research on vaccines during pregnancy: protocol design and assessment of safety.
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Munoz FM, Sheffield JS, Beigi RH, Read JS, Swamy GK, Jevaji I, Rasmussen SA, Edwards KM, Fortner KB, Patel SM, Spong CY, Ault K, Heine RP, and Nesin M
- Subjects
- Female, Humans, Infant, Newborn, Infant, Newborn, Diseases prevention & control, Pregnancy, Pregnancy Complications, Infectious prevention & control, Vaccination, Vaccines adverse effects, Vaccines therapeutic use, Clinical Trials as Topic methods, Research Design
- Abstract
The Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health organized a series of conferences, entitled "Enrolling Pregnant Women in Clinical Trials of Vaccines and Therapeutics", to discuss study design and the assessment of safety in clinical trials conducted in pregnant women. A panel of experts was charged with developing guiding principles for the design of clinical trials and the assessment of safety of vaccines during pregnancy. Definitions and a grading system to evaluate local and systemic reactogenicity, adverse events, and other events associated with pregnancy and delivery were developed. The purpose of this report is to provide investigators interested in vaccine research in pregnancy with a basic set of tools to design and implement maternal immunization studies which may be conducted more efficiently using consistent definitions and grading of adverse events to allow the comparison of safety reports from different trials. These guidelines and safety assessment tools may be modified to meet the needs of each particular protocol based on evidence collected as investigators use them in clinical trials in different settings and share their findings and expertise., (Copyright © 2013 Elsevier Ltd. All rights reserved.)
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- 2013
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35. Immunogenicity and efficacy of influenza immunization during pregnancy: recent and ongoing studies.
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Adegbola R, Nesin M, and Wairagkar N
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- Female, Global Health, Health Promotion, Humans, Influenza Vaccines immunology, Influenza, Human immunology, Practice Guidelines as Topic, Pregnancy, Pregnancy Complications, Infectious immunology, Vaccines, Inactivated administration & dosage, Vaccines, Inactivated immunology, Influenza Vaccines administration & dosage, Influenza, Human prevention & control, Pregnancy Complications, Infectious prevention & control, Prenatal Care, Vaccination
- Abstract
Pregnant women and young infants are at increased risk from influenza. The World Health Organization and public health guidelines from Australia, Canada, and the United States recommend immunizing pregnant women with trivalent inactivated influenza vaccine. However, there are multiple barriers to the uptake of this recommendation. Additionally, current vaccines are not licensed for infants <6 months of age. Immunizing pregnant women would provide protection to both mothers and infants. The Bill & Melinda Gates Foundation (BMGF) and the National Institute of Allergy and Infectious Diseases (NIAID) are trying to address some of the issues associated with maternal immunization, which could be an effective intervention in both high- and low-resource settings to combat the significant maternal and infant morbidity and mortality due to influenza. BMGF and NIAID efforts are complementary to each other, focusing on evaluating the immunogenicity, efficacy, and safety of influenza vaccines during pregnancy; and the potential effect of maternal immunization on outcomes in infants in low-resource populations., (Copyright © 2012 Mosby, Inc. All rights reserved.)
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- 2012
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36. In vivo capsular switch in Streptococcus pneumoniae--analysis by whole genome sequencing.
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Hu FZ, Eutsey R, Ahmed A, Frazao N, Powell E, Hiller NL, Hillman T, Buchinsky FJ, Boissy R, Janto B, Kress-Bennett J, Longwell M, Ezzo S, Post JC, Nesin M, Tomasz A, and Ehrlich GD
- Subjects
- Adult, Animals, Animals, Outbred Strains, Chinchilla, Drug Resistance, Multiple, Bacterial, Female, Genome, Bacterial, High-Throughput Nucleotide Sequencing, Humans, Mice, Phenotype, Polymorphism, Single Nucleotide, Sequence Analysis, DNA, Streptococcus pneumoniae pathogenicity, Virulence, Bacteremia microbiology, Bacterial Capsules genetics, Genes, Bacterial, Pneumococcal Infections microbiology, Streptococcus pneumoniae genetics
- Abstract
Two multidrug resistant strains of Streptococcus pneumoniae - SV35-T23 (capsular type 23F) and SV36-T3 (capsular type 3) were recovered from the nasopharynx of two adult patients during an outbreak of pneumococcal disease in a New York hospital in 1996. Both strains belonged to the pandemic lineage PMEN1 but they differed strikingly in virulence when tested in the mouse model of IP infection: as few as 1000 CFU of SV36 killed all mice within 24 hours after inoculation while SV35-T23 was avirulent.Whole genome sequencing (WGS) of the two isolates was performed (i) to test if these two isolates belonging to the same clonal type and recovered from an identical epidemiological scenario only differed in their capsular genes? and (ii) to test if the vast difference in virulence between the strains was mostly - or exclusively - due to the type III capsule. WGS demonstrated extensive differences between the two isolates including over 2500 single nucleotide polymorphisms in core genes and also differences in 36 genetic determinants: 25 of which were unique to SV35-T23 and 11 unique to strain SV36-T3. Nineteen of these differences were capsular genes and 9 bacteriocin genes.Using genetic transformation in the laboratory, the capsular region of SV35-T23 was replaced by the type 3 capsular genes from SV36-T3 to generate the recombinant SV35-T3* which was as virulent as the parental strain SV36-T3* in the murine model and the type 3 capsule was the major virulence factor in the chinchilla model as well. On the other hand, a careful comparison of strains SV36-T3 and the laboratory constructed SV35-T3* in the chinchilla model suggested that some additional determinants present in SV36 but not in the laboratory recombinant may also contribute to the progression of middle ear disease. The nature of this determinants remains to be identified.
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- 2012
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37. Neonatal cord blood subsets and cytokine response to bacterial antigens.
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Peoples JD, Cheung S, Nesin M, Lin H, Tatad AM, Hoang D, Perlman JM, and Cunningham-Rundles S
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- Adult, Cells, Cultured, Chemokines immunology, Chemokines metabolism, Confidence Intervals, Cytokines immunology, Female, Fetal Blood immunology, Humans, Infant, Newborn, Infant, Very Low Birth Weight, Interleukin-10 immunology, Interleukin-10 metabolism, Interleukin-12 immunology, Interleukin-12 metabolism, Killer Cells, Natural immunology, Killer Cells, Natural metabolism, Leukocytes immunology, Leukocytes metabolism, Male, Probability, Sensitivity and Specificity, T-Lymphocyte Subsets immunology, T-Lymphocyte Subsets metabolism, Term Birth, Antigens, Bacterial pharmacology, Cytokines metabolism, Fetal Blood cytology, Lymphocyte Activation immunology
- Abstract
We compared lymphocyte subsets and cytokine responses to bacteria among term, preterm infants, and adults. Lymphocyte subset percentages in cord blood (22 preterm, 27 term neonates) and peripheral blood from 21 adults and cytokine/chemokine interleukin (IL)-6, IL-8, IL-10, IL-12, interferon gamma (IFN gamma) responses to Escherichia coli, group B Streptococcus (GBS), Staphylococcus epidermidis, and Lactobacillus plantarum (Lp299v) were assessed by flow cytometry. Preterm compared with term infants had increased CD8 (+) T cells (p = 0.02) and reduced naïve CD4 (+) T cells (p < 0.0001). Memory T and natural killer (NK) T cells were reduced (p < 0.001) in neonates; NK and CD56 (+)161 (+) NK cells were increased (p < 0.001). CD56 (+)CD8 (+) NK cells were higher in preterm compared with term infants. Despite individual exceptions, cytokine responses in neonates were weaker than adults except for IL-8 response to E. coli in preterm and IL-12 response to Lp299v in term infants. IL-10 responses were weaker in preterm (p = 0.01) and term (p = 0.005) infants to S. epidermidis and to E. coli (p = 0.03 for both) compared with adults. Differences in regulatory subpopulations of NK and T cells between neonates and adults and term compared with preterm infants were observed. These differences rather than intrinsic functional deficiency may account for neonatal cytokine responses to bacteria., (Thieme Medical Publishers.)
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- 2009
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38. Maternal and neonatal characteristics associated with neonatal neutropenia in hypertensive pregnancies.
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Sharma G, Nesin M, Feuerstein M, and Bussel JB
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- Blood Pressure Determination, Case-Control Studies, Chi-Square Distribution, Female, Follow-Up Studies, Gestational Age, Humans, Hypertension, Pregnancy-Induced epidemiology, Incidence, Infant, Newborn, Infant, Newborn, Diseases epidemiology, Male, Neutropenia epidemiology, Pre-Eclampsia diagnosis, Pre-Eclampsia epidemiology, Pregnancy, Pregnancy, Multiple, Premature Birth, Probability, Reference Values, Retrospective Studies, Risk Assessment, Sepsis epidemiology, Severity of Illness Index, Statistics, Nonparametric, Survival Analysis, Hypertension, Pregnancy-Induced diagnosis, Infant, Newborn, Diseases diagnosis, Neutropenia diagnosis, Sepsis diagnosis
- Abstract
The purpose of this study was to identify maternal and neonatal characteristics affecting marked neonatal neutropenia in pregnancies complicated by hypertension. A single institution retrospective chart review over 2 years of singleton and multifetal pregnancies with hypertensive disorders meeting American College of Obstetricians and Gynecologists criteria was performed. Neutropenia and sepsis occurring within the first 16 days of life (DOL) were studied. Neutropenia was defined as an absolute neutrophil count of <1500/microL and sepsis as any positive blood, cerebrospinal fluid, or urine culture. The study group contained neonates with neutropenia. From all other hypertensive pregnancies, a presumed nonneutropenic control group was randomly generated with a 4:1 ratio; these neonates may or may not have had a complete blood count (CBC) performed because they were clinically stable. Multiple gestations were separately analyzed and compared with hypertensive multifetal neonates with confirmed CBCs showing no neutropenia. Chi-square, Mann-Whitney U, and regression analyses were performed. Five hundred forty-three hypertensive pregnancies representing 633 births, 173 (27.3%) of which were from multiple gestations, were studied. There were 32 (5.9%) cases of neutropenia, with 22 (68.8%) from multiple gestations. Of premature multiple gestations, 45.2% born between 24 and 34 weeks' gestation developed neutropenia. The median time to diagnosis of neutropenia was 1.2 hours with 80.6% detected on the first DOL. Resolution of neutropenia occurred within 7 days in 84.4% of surviving neonates. Univariate analysis showed significant associations of neutropenia with gestational age at delivery, multiple gestations, birth weight, severe preeclampsia, and development of neonatal sepsis. When multiple gestations were analyzed, linear regression showed only sepsis to be significantly associated with neutropenia (p = 0.027). Hypertensive disorders of pregnancy and premature delivery are common in multiple gestations and are associated with neutropenia (12.7% versus 2.2% neutropenia in singletons (p < 0.001). Furthermore, multiple gestations with neutropenia had a higher incidence of sepsis than singletons with neutropenia., (Thieme Medical Publishers.)
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- 2009
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39. Phase 1/2 double-blind, placebo-controlled, dose escalation, safety, and pharmacokinetic study of pagibaximab (BSYX-A110), an antistaphylococcal monoclonal antibody for the prevention of staphylococcal bloodstream infections, in very-low-birth-weight neonates.
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Weisman LE, Thackray HM, Garcia-Prats JA, Nesin M, Schneider JH, Fretz J, Kokai-Kun JF, Mond JJ, Kramer WG, and Fischer GW
- Subjects
- Antibodies, Monoclonal administration & dosage, Antibodies, Monoclonal adverse effects, Double-Blind Method, Humans, Infant, Newborn, Antibodies, Monoclonal pharmacokinetics, Antibodies, Monoclonal therapeutic use, Infant, Very Low Birth Weight, Staphylococcal Infections prevention & control
- Abstract
Staphylococcal sepsis is a major cause of morbidity and mortality in very-low-birth-weight (VLBW) infants. A human chimeric monoclonal antibody, pagibaximab, was developed against staphylococcal lipoteichoic acid. We evaluated the safety, tolerability, and pharmacokinetics of pagibaximab in VLBW neonates. A phase 1/2, randomized, double-blind, placebo-controlled, dose escalation study was conducted in VLBW infants (700 to 1,300 g) 3 to 7 days old. Patients received two doses 14 days apart of intravenous pagibaximab (10, 30, 60, or 90 mg/kg of body weight) or placebo in a 2:1 ratio. Blood and urine samples were obtained pre- and postinfusion for analysis of safety and pharmacokinetics, and data on adverse events were gathered. Staphylococcal organisms causing sepsis were collected and evaluated. Fifty-three patients received at least one dose of pagibaximab or placebo. The average gestational age was 27.6 weeks; the average birth weight was 1,003 g. All serious adverse events were deemed unrelated or probably not drug related. Morbidity and mortality were similar across treatment groups. No evidence of immunogenicity of pagibaximab was detected. Pagibaximab pharmacokinetics was linear. The mean clearance (CL), volume of distribution, and elimination half-life of pagibaximab were independent of dose. The serum half-life was 20.5 +/- 6.8 days. Pagibaximab enhanced serum opsonophagocytic activity. All staphylococci causing sepsis were opsonizable by pagibaximab. Two infusions of pagibaximab, administered 2 weeks apart to high-risk neonates appeared safe and tolerable, and pharmacokinetics were linear. Evaluation of more frequent doses, at the highest doses tested, in neonates at high-risk of staphylococcal sepsis, is warranted.
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- 2009
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40. Cytokine expression in response to bacterial antigens in preterm and term infant cord blood monocytes.
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Tatad AM, Nesin M, Peoples J, Cheung S, Lin H, Sison C, Perlman J, and Cunningham-Rundles S
- Subjects
- Adult, Antigens, Bacterial immunology, Cells, Cultured, Escherichia coli immunology, Female, Humans, Infant, Newborn, Infant, Premature, Interleukin-10 metabolism, Interleukin-12 metabolism, Interleukin-6 metabolism, Interleukin-8 metabolism, Lactobacillus plantarum immunology, Male, Middle Aged, Monocytes cytology, Monocytes drug effects, Staphylococcus epidermidis immunology, Antigens, Bacterial pharmacology, Cytokines metabolism, Fetal Blood cytology, Monocytes metabolism
- Abstract
Background: Neonatal susceptibility to bacterial infection is associated with an immature immune system, but the role of different bacterial antigens in specific responses is largely unknown., Objective: To evaluate differences in intracellular cytokine response to physiologically relevant bacterial antigens in term and preterm infants as compared with adults., Methods: Cord blood samples from preterm and term neonates and adult peripheral blood samples were cultured ex vivo with and without whole heat-killed bacteria. Intracellular leukocyte production of interleukin (IL)-6, IL-10, IL-12, and IL-8 responses was assessed by flow cytometry., Results: Monocytes were the primary producers of all mediators. Escherichia coli was the most potent stimulant. Lactobacillus plantarum 299v activated fewer monocytes as compared with E. coli for all responses (p < 0.05), except for IL-12 in term neonates. IL-6 response to Staphylococcus epidermidis was lower in both groups of neonates as compared with adults (p = 0.023 and p = 0.001). IL-8 response to S. epidermidis was lower in term as compared with preterm neonates and adults (p = 0.003). IL-10 response to group B streptococci was lower in term neonates as compared with adults and higher in preterm as compared with term neonates (p = 0.015)., Conclusions: Monocytes from term neonates compared to preterm neonates show a downregulated anti-inflammatory response to specific bacteria. High neonatal response to pathogenic E. coli in the preterm infant could cause uncontrolled inflammatory response, while lower IL-6 response to S. epidermidis in neonates may indicate a basis for vulnerability to S. epidermidis infection., ((c) 2007 S. Karger AG, Basel.)
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- 2008
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41. Levels of pro-inflammatory cytokines produced from cord blood in-vitro are pathogen dependent and increased in comparison to adult controls.
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Mohamed MA, Cunningham-Rundles S, Dean CR, Hammad TA, and Nesin M
- Subjects
- Adult, Cytokines blood, Cytokines metabolism, Escherichia coli immunology, Female, Fetal Blood metabolism, Humans, Infant, Newborn, Interleukin-1beta biosynthesis, Interleukin-1beta blood, Interleukin-6 biosynthesis, Interleukin-6 blood, Interleukin-8 biosynthesis, Interleukin-8 blood, Male, Staphylococcus epidermidis immunology, Streptococcus agalactiae immunology, Tumor Necrosis Factor-alpha biosynthesis, Tumor Necrosis Factor-alpha blood, Cytokines biosynthesis, Fetal Blood immunology, Gram-Negative Bacteria immunology, Gram-Positive Bacteria immunology, Inflammation Mediators blood, Up-Regulation immunology
- Abstract
Background: Overproduction of pro-inflammatory cytokines may play a role in increased morbidity and mortality from neonatal sepsis. Objective of this study was to compare secretion of pro-inflammatory cytokines by the cord blood cells of healthy term neonates to the venous blood cells of healthy adults in vitro after stimulation with common neonatal pathogens., Method: Blood samples were cultured in the presence of heat-killed group B beta-hemolytic streptococci (GBS), Escherichia coli (E. coli) and Staphylococcus epidermidis (S. epi). Concentrations of secreted cytokines (interleukine-6, IL-6, tumor necrosis factor-alpha, TNF-alpha, interleukine-1 beta, IL-1beta and interleukine-8, IL-8) were measured after 0, 1, 2 and 4 h of incubation using chemiluminescent immunometric automated assay., Results: Blood samples from 22 neonates and 16 adults were compared. After stimulation by GBS and E. coli, cord blood cells secreted significantly higher levels of IL-6 and IL-8 than blood cells of healthy adults. In cord blood, E. coli induced secretion of higher concentration of IL-6, TNF-alpha, IL-1beta and IL-8 than S. epi, and more IL-6 than GBS; GBS induced more IL-1beta than S.epi., Conclusions: Response of cord blood to microbial activators is different from that of adult controls. Each isolate of heat-killed bacteria induced different amount of pro-inflammatory cytokines in vitro. This may represent a useful in vitro virulence test.
- Published
- 2007
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42. Genetic basis of preterm birth.
- Author
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Nesin M
- Subjects
- Environment, Female, Genomics, Humans, Polymorphism, Single Nucleotide, Pregnancy, Premature Birth epidemiology, Proteomics, Premature Birth genetics
- Abstract
Epidemiologic data show that women who deliver prematurely often have a personal and/or family history of preterm birth (PTB) and that racial and ethnic differences influence the incidence of PTB. This may indicate genetic predisposition to PTB. However, since races and ethnic groups tend to share environmental factors (exposure to toxins, living conditions, diet, smoking), epidemiologic data may just confirm environmental influences on PTB. Alternatively, PTB may represent a consequence of gene-environment interactions. Infection and inflammation correlate with increased risk for preterm premature rupture of amniotic membranes (PPROM) and PTB. Immunomodulatory molecules and their receptors regulate these processes and many of them are products of polymorphic genes. Single nucleotide polymorphisms (SNPs) of a gene may lead to a differential expression of its product. So far, SNPs for several genes have been implicated in PTB. If it is confirmed that polymorphism(s) in particular gene(s) correlates with PTB, it may become possible to develop targeted diagnostic and therapeutic approaches tailored towards unique genetic characteristics of a mother/fetus pair.
- Published
- 2007
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43. Enhancement of umbilical cord blood cell hematopoiesis by maitake beta-glucan is mediated by granulocyte colony-stimulating factor production.
- Author
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Lin H, Cheung SW, Nesin M, Cassileth BR, and Cunningham-Rundles S
- Subjects
- Fetal Blood, Granulocyte Colony-Stimulating Factor biosynthesis, Hematopoiesis physiology, Humans, beta-Glucans isolation & purification, Granulocyte Colony-Stimulating Factor metabolism, Grifola chemistry, Hematopoiesis drug effects, Hematopoietic Stem Cells drug effects, beta-Glucans pharmacology
- Abstract
Maitake beta-glucan (MBG) is an extract from the fruit body of the Grifola frondosa mushroom that is being widely used to treat cancer in Asia. We have previously reported that MBG enhances mouse bone marrow cell (BMC) hematopoiesis in vitro and protects BMC from doxorubicin (DOX) toxicity. In the current study, we investigated the ability of MBG to enhance hematopoiesis and to reduce the toxic effects of DOX on fresh human umbilical cord blood (CB) cells. MBG treatment significantly enhanced the colony formation unit (CFU) response of granulocytes-macrophages (CFU-GM response) over the whole dose range of 12.5 to 100 microg/ml (P < 0.05). The addition of MBG to DOX-treated CB cells significantly protected granulocyte-macrophage colony formation from the toxicity of DOX, which otherwise produced strong hematopoietic repression. MBG also partially replaced recombinant human granulocyte colony-stimulating factor (rhG-CSF), as shown by a significant augmentation of the CFU-GM response in the absence of rhG-CSF. We found that MBG induces granulocyte colony-stimulating factor (G-CSF) production in CB CD33+ monocytes, as detected by intracellular cytokine flow cytometric assessment. In contrast, we found that adult peripheral blood monocytes did not produce a significant G-CSF response to MBG, whereas both adult and CB monocytes produced G-CSF in response to lipopolysaccharide. These studies provide the first evidence that MBG induces hematopoietic stem cell proliferation and differentiation of CFU-GM in umbilical CB cells and acts directly to induce G-CSF.
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- 2007
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44. Dexamethasone suppresses expression of Nuclear Factor-kappaB in the cells of tracheobronchial lavage fluid in premature neonates with respiratory distress.
- Author
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Aghai ZH, Kumar S, Farhath S, Kumar MA, Saslow J, Nakhla T, Eydelman R, Strande L, Stahl G, Hewitt C, Nesin M, and Rahman I
- Subjects
- Humans, Infant, Newborn, NF-kappa B metabolism, Bronchi pathology, Bronchoalveolar Lavage Fluid cytology, Dexamethasone pharmacology, Infant, Premature, NF-kappa B antagonists & inhibitors, Respiratory Distress Syndrome, Newborn blood, Trachea pathology
- Abstract
Nuclear Factor-kappaB (NF-kappaB) plays a central role in regulating the key mediators of inflammation involved in acute lung injury. The anti-inflammatory effect of steroids by suppressing pro-inflammatory cytokines may be mediated by inhibition of transcription factor NF-kappaB. The objective of this study was to determine the effect of glucocorticoid therapy on the expression of NF-kappaB in the cells of tracheobronchial lavage fluid (TBLF) in premature neonates with respiratory distress. Nineteen premature neonates requiring mechanical ventilation and receiving glucocorticoids were enrolled. Their gestational age (mean +/- SD) was 25.0 +/- 1.2 wk, birth weight 714 +/- 105 g and age of starting dexamethasone was 33 +/- 15 d. Tracheobronchial lavage fluid was collected before and 48-72 h after starting dexamethasone. NF-kappaB expression was measured by immunocytochemistry using mouse MAb against the p65 subunit of NF-kappaB on cytospin slides. The percent of cells stained and the intensity staining index were significantly higher before starting dexamethasone compared with after steroid therapy. Localization of NF-kappaB was significantly decreased in the cytoplasm and nuclei of mononuclear cells after initiation of dexamethasone therapy. The concentration of IL-8 was also significantly lower after starting dexamethasone. In conclusion, dexamethasone suppressed the expression of NF-kappaB in the cytoplasm and nuclei of mononuclear cells and decreased levels of IL-8 in TBLF from premature neonates with respiratory distress. The anti-inflammatory effects of corticosteroids may be mediated through NF-kappaB.
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- 2006
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45. Longitudinal changes of brain-type natriuretic peptide in preterm neonates.
- Author
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da Graca RL, Hassinger DC, Flynn PA, Sison CP, Nesin M, and Auld PA
- Subjects
- Ductus Arteriosus, Patent therapy, Female, Humans, Infant, Newborn, Male, Prospective Studies, Respiration, Artificial, Ductus Arteriosus, Patent blood, Infant, Premature blood, Natriuretic Peptide, Brain blood
- Abstract
Objective: To determine age-related concentrations of brain-type natriuretic peptide in preterm infants using bedside Triage brain-type natriuretic peptide test and correlate it to the presence or absence of the patent ductus arteriosus and ventilatory support., Methods: Serum brain-type natriuretic peptide levels were measured in infants who were born at <32 weeks' gestation from birth to 2 months of age. Serial echocardiograms were performed, until closure of the patent ductus arteriosus, or until discharge. Brain-type natriuretic peptide levels were correlated to the day of life, gestational age, presence or absence of the patent ductus arteriosus, and the degree of ventilatory support. Nineteen preterm infants (gestational age: 24-31 weeks; birth weight: 645-1670 g) were enrolled prospectively during the first 2 weeks of life. Serum brain-type natriuretic peptide levels (pg/mL) were determined in 177 blood samples, and 87 paired echocardiograms were performed., Results: Significant negative correlation was found between brain-type natriuretic peptide levels and the day of life and remained significant when the patients were stratified by gestational age (< or =28 weeks and >28 weeks). Higher brain-type natriuretic peptide levels correlated with increasing grade of the patent ductus arteriosus. Significant differences in brain-type natriuretic peptide levels were seen with increasing ventilatory support. Comparisons between the size of patent ductus arteriosus and the degree of ventilatory support to brain-type natriuretic peptide levels revealed that the size of the patent ductus arteriosus was the major determinant of both brain-type natriuretic peptide levels and the degree of ventilatory support., Conclusions: Similar to term infants, brain-type natriuretic peptide levels of preterm infants are related to the chronological age and decline during the first month of life. Rapid bedside Triage brain-type natriuretic peptide is a potentially valuable and practical assay in determining the hemodynamic changes in preterm infants.
- Published
- 2006
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46. Serial cytokine profiles in shunt-related ventriculitis treated with intraventricular vancomycin.
- Author
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Laborada G, Cruz F, and Nesin M
- Subjects
- Cytokines drug effects, Drug Monitoring, Encephalitis diagnosis, Encephalitis etiology, Female, Humans, Infant, Newborn, Infant, Premature, Injections, Intraventricular, Staphylococcal Infections diagnosis, Staphylococcal Infections etiology, Ventriculoperitoneal Shunt adverse effects, Anti-Bacterial Agents administration & dosage, Cytokines cerebrospinal fluid, Encephalitis drug therapy, Methicillin Resistance, Staphylococcal Infections drug therapy, Vancomycin administration & dosage
- Abstract
Background: A 1-month-old premature infant developed persistent shunt-related methicillin-resistant Staphylococcus aureus ventriculitis that was not responsive to parenteral therapy with vancomycin plus gentamicin (or rifampin)., Methods: The infant was treated by intraventricular administration of vancomycin (5 days: 10 mg/day). In addition to standard testing of the cerebrospinal fluid (CSF), tumor necrosis factor alpha, interleukin-8 and interleukin-6 were serially measured., Results: Sterilization of the CSF was followed by a decline in the number of WBC and proinflammatory cytokines in the CSF., Conclusion: Intraventricular administration of antibiotics may be considered if ventriculitis is refractory to systemic antimicrobial therapy. Serial measurements of inflammatory cytokines in the CSF may provide an additional diagnostic tool to monitor the outcome of therapy., (Copyright 2005 S. Karger AG, Basel.)
- Published
- 2005
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47. Risk factors for candidemia in critically ill infants: a matched case-control study.
- Author
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Feja KN, Wu F, Roberts K, Loughrey M, Nesin M, Larson E, Della-Latta P, Haas J, Cimiotti J, and Saiman L
- Subjects
- Case-Control Studies, Catheterization adverse effects, Female, Humans, Incidence, Infant, Newborn, Intensive Care Units, Neonatal, Male, New York City epidemiology, Respiration, Artificial adverse effects, Risk Factors, Candidiasis etiology, Cross Infection etiology
- Abstract
Objective: To determine risk factors for late-onset candidemia among infants in the neonatal intensive care unit (NICU)., Study Design: We performed a matched case-control study from March 2001 to January 2003 in 2 level III-IV NICUs. Case subjects had candidemia diagnosed more than 48 hours after hospitalization. Control subjects (3 per case) were matched by study site, birth weight, study year, and date of enrollment. Potential risk factors included medical devices, medications, gastrointestinal (GI) pathology (congenital anomalies or necrotizing enterocolitis) and previous bacterial bloodstream infections (BSIs)., Results: Forty-five cases of candidemia occurred during the study period and accounted for 15% of BSIs. C. albicans caused 62% of infections (28/45); C. parapsilosis, 31% (14/45). Multivariate analysis revealed that catheter use (odds ratio [OR]=1.06 per day of use; 95% confidence interval [CI]=1.02 to 1.10), previous bacterial BSIs (OR=8.02; 95% CI=2.76 to 23.30) and GI pathology (OR=4.57; 95% CI=1.62 to 12.92) were significantly associated with candidemia. In all, 26/45 cases (58%) of candidemia occurred in infants who would not have qualified for fluconazole prophylaxis according to the Kaufman criteria., Conclusions: We confirmed previous risk factors (catheter-days) and identified novel risk factors (previous BSI and GI pathology) for candidemia in critically ill infants that could guide future targeted antifungal prophylaxis strategies.
- Published
- 2005
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48. The use of a bedside assay for plasma B-type natriuretic peptide as a biomarker in the management of patent ductus arteriosus in premature neonates.
- Author
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Flynn PA, da Graca RL, Auld PA, Nesin M, and Kleinman CS
- Subjects
- Biomarkers, Echocardiography, Fluorescent Antibody Technique, Humans, Infant, Newborn, Sensitivity and Specificity, Ductus Arteriosus, Patent diagnosis, Infant, Premature, Natriuretic Peptide, Brain blood, Neonatal Screening methods, Point-of-Care Systems
- Abstract
Objective: To test the utility of the bedside plasma concentration of B-type natriuretic peptide (BNP) assay as a screen for patent ductus arteriosus (PDA) in premature neonates., Study Design: Newborn infants admitted to the neonatal intensive care unit (NICU) had paired echocardiography and BNP measurements at enrollment and every 4 to 5 days., Results: Twenty neonates (gestational age approximately 28.6 weeks and birth weight approximately 1161 g) had 81 paired echocardiography and BNP determinations. BNP ranged from 5 to 3900 pg/mL. Fifty-six of 81 echocardiograms showed PDA. Significant correlations were found between BNP and ductal size and degree of shunting. Correlation was greater in infants >2 days of age. BNP >300 pg/mL predicted significant PDA, whereas BNP <105 pg/mL predicted absence of significant PDA., Conclusion: Bedside measurement of BNP correlates with magnitude of PDA in premature newborns, particularly beyond day 2, and may be useful in guiding diagnostic and management strategies.
- Published
- 2005
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49. Interleukin-6 and interleukin-8 are elevated in the cerebrospinal fluid of infants exposed to chorioamnionitis.
- Author
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Laborada G and Nesin M
- Subjects
- Chorioamnionitis immunology, Female, Humans, Infant, Newborn, Infant, Premature, Male, Pregnancy, Term Birth, Chorioamnionitis cerebrospinal fluid, Interleukin-6 cerebrospinal fluid, Interleukin-8 cerebrospinal fluid
- Abstract
Background: The clinical or histologic diagnosis of chorioamnionitis has been associated with an increased risk of neuropathology and adverse neurologic outcomes in premature and term infants. Inflammatory cytokines have been implicated in the pathogenesis of these processes. The objective of this study was to determine whether exposure to chorioamnionitis and fetal inflammatory syndrome is associated with elevated concentrations of inflammatory cytokines (TNF-alpha, IL-6, and IL-8) in the CSF of term and preterm infants., Methods: Eighty-four mother/infant pairs were studied, 54 infants were premature. Twenty-eight showed signs of maternal (n = 14), or fetal (n = 14) inflammation based on placental pathology; mothers of 24 infants showed signs of clinical chorioamnionitis not confirmed by placental pathology and 32 infants were considered as 'controls' since they had only transient difficulty adjusting to extra-uterine life warranting evaluation for sepsis. The cytokine concentrations in the CSF were measured within 24 h of birth., Results: When compared to the control group (IL-8 = 341 +/- 170 pg/ml and IL-6 = 7.4 +/- 1.8 pg/ml) significantly higher concentrations of IL-8 were detected in the CSF of infants exposed to clinical chorioamnionitis (1,854 +/- 878 pg/ml; p = 0.001) and maternal/fetal inflammation (1,754 +/- 787 pg/ml; p = 0.001) and of IL-6 in infants with maternal/fetal inflammation (47.6 +/- 45.1 pg/ml; p = 0.01)., Conclusions: These results indicate that infants exposed to clinical chorioamnionitis, or inflammation in utero, experience at least a transient elevation in inflammatory cytokines in CSF., (Copyright (c) 2005 S. Karger AG, Basel.)
- Published
- 2005
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50. Emergence of resistant staphylococci on the hands of new graduate nurses.
- Author
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Cimiotti JP, Wu F, Della-Latta P, Nesin M, and Larson E
- Subjects
- Cohort Studies, Electrophoresis, Gel, Pulsed-Field, Intensive Care Units, Neonatal, New York City, Species Specificity, Staphylococcus aureus drug effects, Staphylococcus epidermidis drug effects, Workforce, Education, Nursing, Graduate, Methicillin Resistance, Nursing Staff, Hospital, Staphylococcus aureus isolation & purification, Staphylococcus epidermidis isolation & purification
- Abstract
Objective: To describe the aerobic microbial flora on the hands of experienced and new graduate nurses over time., Design: A prospective cohort design that examined the relationship between duration of employment in an intensive care unit (ICU) and the microbial flora on the hands of experienced and new graduate nurses during a 23-month period., Setting: A 50-bed, level III-IV neonatal ICU in New York City., Participants: Twelve experienced nurses and 9 new graduate nurses working full time in the NICU., Intervention: One hundred fifty samples were obtained from the clean, dominant hands of the nurses. Cultures were performed at baseline and then quarterly for each experienced and new graduate nurse. Baseline and final cultures of Staphylococcus epidermidis were further examined using pulsed-field gel electrophoresis., Results: At baseline, a significantly larger proportion of the experienced nurses had methicillin-resistant, coagulase-negative staphylococci isolated from their hands compared with the new graduate nurses (95% and 33%, respectively; P = .0004). For a second culture, performed 1 to 4 months later, there were no longer significant differences between the two groups (82% and 54%, respectively; P = .12). By the last culture, all staphylococcal isolates were methicillin resistant in both groups of nurses; 3 were methicillin-resistant S. aureus., Conclusions: Colonization with methicillin-resistant staphylococci occurred after brief exposure to the hospital environment, despite the use of antiseptic hand hygiene agents. Furthermore, at final culture, the two groups shared one dominant hospital-acquired strain of S. epidermidis.
- Published
- 2004
- Full Text
- View/download PDF
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