Neonatal infections: Case definition and guidelines for data collection, analysis, and presentation of immunisation safety data

Vaccine

Volumn 34, Issue 49, 2016, Pages 6038-6046

  Vergnano, Stefania ^a   Buttery, Jim ^b   Cailes, Ben ^a   Chandrasekaran, Ravichandran ^c   Chiappini, Elena ^d   Clark, Ebiere ^e   Cutland, Clare ^f   de Andrade, Solange Dourado ^g   Esteves Jaramillo, Alejandra ^h   Guinazu, Javier Ruiz ⁱ   Jones, Chrissie ^a   Kampmann, Beate ^j,k   King, Jay ^h   Kochhar, Sonali ^l   Macdonald, Noni ^m   Mangili, Alexandra ⁿ   de Menezes Martins, Reinaldo ^o   Velasco Muñoz, César ^p   Padula, Michael ^q   Muñoz, Flor M ^r   Oleske, James ^s   Sanicas, Melvin ^t   Schlaudecker, Elizabeth ^u   Spiegel, Hans ^v   Subelj, Maja ^w   Sukumaran, Lakshmi ^x   Tagbo, Beckie N ^y   Top, Karina A ^m   Tran, Dat ^z   Heath, Paul T ^a   more..

^a ST GEORGE'S UNIVERSITY OF LONDON   (United Kingdom)

^b MONASH MEDICAL CENTRE   (Australia)

^c MADRAS MEDICAL COLLEGE   (India)

^d UNIVERSITY OF FLORENCE   (Italy)

^e Enhanced Vigilance Systems   (United Kingdom)

^f UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^g Fundação de Medicina Tropical Dr Heitor Vieira Dourado   (Brazil)

^h SANOFI PASTEUR   (France)

ⁱ GSK   (Belgium)

^j IMPERIAL COLLEGE LONDON   (United Kingdom)

^k MRC Unit   (Gambia)

^l Global Healthcare Consulting   (India)

^m DALHOUSIE UNIVERSITY   (Canada)

ⁿ Novartis Vaccine GSK Vaccines   (United States)

^o Instituto de Technologia em Imunobiologicos   (Brazil)

^p CENTRE FOR RESEARCH IN ENVIRONMENTAL EPIDEMIOLOGY CREAL   (Spain)

^q CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

^r BAYLOR COLLEGE OF MEDICINE   (United States)

^s RUTGERS NEW JERSEY MEDICAL SCHOOL   (United States)

^t BILL AND MELINDA GATES FOUNDATION   (United States)

^u CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

^v Henry Jackson Foundation   (United States)

^w Regional Unit Novo Mesto   (Slovenia)

^x EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^y UNIVERSITY OF NIGERIA   (Nigeria)

^z HOSPITAL FOR SICK CHILDREN   (Canada)

more..

Author keywords

Adverse event; Bacteremia; Bronchiolitis; Case definition; Guidelines; Immunisation; Meningitis; Neonatal infections; Newborn; Perinatal; Pneumonia; Possible bacterial infection; Sepsis

Indexed keywords

VACCINE;

ARTICLE; BACTERIAL INFECTION; BLOODSTREAM INFECTION; DATA ANALYSIS; DRUG SAFETY; HUMAN; INFORMATION PROCESSING; LOWER RESPIRATORY TRACT INFECTION; MENINGITIS; MYCOSIS; NEWBORN INFECTION; PRACTICE GUIDELINE; PRIORITY JOURNAL; RESPIRATORY TRACT INFECTION; SYSTEMATIC REVIEW; TIME; VACCINATION; VIRUS INFECTION; BACTEREMIA; COMMUNICABLE DISEASE CONTROL; FEMALE; IMMUNIZATION; INFECTION; NEWBORN; SEPSIS; STATISTICS;

BACTEREMIA; COMMUNICABLE DISEASE CONTROL; DATA COLLECTION; FEMALE; HUMANS; IMMUNIZATION; INFANT, NEWBORN; INFECTION; MENINGITIS; SEPSIS; STATISTICS AS TOPIC; VACCINES;

EID: 84998679671     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2016.03.046     Document Type: Article

References (25)

1. [1] Nuccitelli, A., Rinaudo, C.D., Maione, D., Group B Streptococcus vaccine: state of the art. Ther Adv Vaccines, 2015, 10.1177/2051013615579869.
2. [2] Hayles, E.H., Cooper, S.C., Wood, N., Sinn, J., Skinner, S.R., What predicts postpartum pertussis booster vaccination? A controlled intervention trial. Vaccine 33:1 (2015), 228–236.
3. [3] Liu, L., Oza, S., Hogan, D., Perin, J., Rudan, I., Lawn, J.E., et al. Global, regional, and national causes of child mortality in 2000–13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet 385:9966 (2015), 430–440.
4. [4] GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age–sex specific all-cause and cause-specific mortality for 240 causes of death, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet 385:9963 (2015), 117–171.
5. [5] Young Infants Clinical Signs Study Group. Clinical signs that predict severe illness in children under age 2 months: a multicentre study. Lancet 371:9607 (2008), 135–142.
6. [6] Vergnano, S., Fottrell, E., Osrin, D., Kazembe, P.N., Mwansambo, C., Manandhar, D.S., et al. Adaptation of a probabilistic method (InterVA) of verbal autopsy to improve the interpretation of cause of stillbirth and neonatal death in Malawi, Nepal, and Zimbabwe. Popul Health Metr, 9, 2011, 48, 10.1186/1478-7954-9-48.
7. [7] Stoll, B.J., Hansen, N.I., Sanchez, P.J., Faix, R.G., Poindexter, B.B., Van Meurs, K.P., et al. Early onset neonatal sepsis: the burden of group B Streptococcal and E. coli disease continues. Pediatrics 127:5 (2011), 817–826.
8. [8] Shah, P.S., Lee, S.K., Lui, K., Sjors, G., Mori, R., Reichman, B., et al. The International Network for Evaluating Outcomes of very low birth weight, very preterm neonates (iNeo): a protocol for collaborative comparisons of international health services for quality improvement in neonatal care. BMC Pediatr, 14, 2014, 110, 10.1186/1471-2431-14-110.
9. [9] Leistner, R., Piening, B., Gastmeier, P., Geffers, C., Schwab, F., Nosocomial infections in very low birthweight infants in Germany: current data from the National Surveillance System NEO-KISS. Klin Padiatr 225:2 (2013), 75–80.
10. [10] Horan, T.C., Andrus, M., Dudeck, M.A., CDC/NHSN surveillance definition of health care–associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control 36:5 (2008), 309–332.
11. [11] Verstraete, E.H., Blot, K., Mahieu, L., Vogelaers, D., Blot, S., Prediction models for neonatal health care-associated sepsis: a meta-analysis. Pediatrics 135:4 (2015), e1002–e1014.
12. [12] Bedford Russell, A.R., Kumar, R., Early onset neonatal sepsis: diagnostic dilemmas and practical management. Arch Dis Child Fetal Neonatal Ed 100:4 (2015), F350–F354.
13. [13] Rao, S., Nyquist, A., Respiratory viruses and their impact in healthcare. Curr Opin Infect Dis 27:4 (2014), 342–347.
14. [14] Wynn, J.L., Wong, H.R., Shanley, T.P., Bizzarro, M.J., Saiman, L., Polin, R.A., Time for a neonatal-specific consensus definition for sepsis. Pediatr Crit Care Med 15:6 (2014), 523–528.
15. [15] Munoz, F.M., Eckert, L.O., Katz, M.A., Lambach, P., Ortiz, J.R., Bauwens, J., et al. Key terms for the assessment of the safety of vaccines in pregnancy: results of a global consultative process to initiate harmonization of adverse event definitions. Vaccine 33:47 (2015), 6441–6452.
16. [16] Opiyo, N., English, M., What clinical signs best identify severe illness in young infants aged 0–59 days in developing countries? A systematic review. Arch Dis Child 96:11 (2011), 1052–1059.
17. [17] Reich, D., Nalls, M.A., Kao, W.H., Akylbekova, E.L., Tandon, A., Patterson, N., et al. Reduced neutrophil count in people of African descent is due to a regulatory variant in the Duffy antigen receptor for chemokines gene. PLoS Genet, 5(1), 2009, e1000360.
18. [18] Garges, H.P., Moody, M.A., Cotten, C.M., Smith, P.B., Tiffany, K.F., Lenfestey, R., et al. Neonatal meningitis: what is the correlation among cerebrospinal fluid cultures, blood cultures, and cerebrospinal fluid parameters?. Pediatrics 117:4 (2006), 1094–1100.
19. [19] Kestenbaum, L.A., Ebberson, J., Zorc, J.J., Hodinka, R.L., Shah, S.S., Defining cerebrospinal fluid white blood cell count reference values in neonates and young infants. Pediatrics 125:2 (2010), 257–264.
20. [20] Greenberg, R.G., Smith, P.B., Cotten, C.M., Moody, M.A., Clark, R.H., Benjamin, D.K. Jr., Traumatic lumbar punctures in neonates: test performance of the cerebrospinal fluid white blood cell count. Pediatr Infect Dis J 27:12 (2008), 1047–1051.
21. [21] Modjarrad, K., Giersing, B., Kaslow, D.C., Smith, P.G., Moorthy, V.S., WHO consultation on Respiratory Syncytial Virus Vaccine Development Report from a World Health Organization Meeting held on 23–24 March 2015. Vaccine, 2015.
22. [22] The Young Infants Clinical Signs Study Group. Clinical signs that predict severe illness in children under age 2 months: a multicentre study. Lancet 371:9607 (2008), 135–142.
23. [23] Michael Marcy, S., Kohl, K.S., Dagan, R., Nalin, D., Blum, M., Jones, M.C., et al. Fever as an adverse event following immunization: case definition and guidelines of data collection, analysis, and presentation. Vaccine 22:5–6 (2004), 551–556.
24. [24] WHO, (eds.) IMCI handbook: integrated management of childhood illness, 2005, UNICEF; WHO, Geneva.
25. [25] Ingle, G., Malhotra, C., Integrated management of neonatal and childhood illness: an overview. Indian J Community Med, 32(2), 2007, 108.