Neonatal death: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

Jayani Pathirana, Flor M Muñoz, Victoria Abbing-Karahagopian, Niranjan Bhat, Tara Harris, Ambujam Kapoor, Daniel L Keene, Alexandra Mangili, Michael A Padula, Stephen L Pande, Vitali Pool, Farshad Pourmalek, Frederick Varricchio, Sonali Kochhar, Clare L Cutland, Brighton Collaboration Neonatal Death Working Group, Jayani Pathirana, Flor M Muñoz, Victoria Abbing-Karahagopian, Niranjan Bhat, Tara Harris, Ambujam Kapoor, Daniel L Keene, Alexandra Mangili, Michael A Padula, Stephen L Pande, Vitali Pool, Farshad Pourmalek, Frederick Varricchio, Sonali Kochhar, Clare L Cutland, Brighton Collaboration Neonatal Death Working Group

Abstract

More than 40% of all deaths in children under 5 years of age occur during the neonatal period: the first month of life. Immunization of pregnant women has proven beneficial to both mother and infant by decreasing morbidity and mortality. With an increasing number of immunization trials being conducted in pregnant women, as well as roll-out of recommended vaccines to pregnant women, there is a need to clarify details of a neonatal death. This manuscript defines levels of certainty of a neonatal death, related to the viability of the neonate, who confirmed the death, and the timing of the death during the neonatal period and in relation to immunization of the mother.

Keywords: Adverse event; Case definition; Guidelines; Maternal immunization; Neonatal death.

Copyright © 2016. Published by Elsevier Ltd.

Figures

Fig. 1
Fig. 1
Neonatal mortality rate in 100,000, age-standardized, both sexes, World Health Organization regions, 2013/Institute for Health Metrics and Evaluation (IHME). GBD Compare. Seattle, WA: IHME, University of Washington, 2015. Available from http://ihmeuw.org/3qjx (accessed 21.12.15).
Fig. 2
Fig. 2
Neonatal mortality, percent of total deaths age-standardized, both sexes, World Health Organization regions, 2013/Institute for Health Metrics and Evaluation (IHME). GBD Compare. Seattle, WA: IHME, University of Washington, 2015. Available from http://ihmeuw.org/3qjy (accessed 21.12.15).
Fig. 3
Fig. 3
Algorithm for the classification of neonatal death.

References

    1. World Health Organization . WHO Libr.; 2006. Neonatal and perinatal mortality: country, regional and global estimates.
    1. UNICEF, WHO, The World Bank, UN; New York, USA: 2014. Levels and trends in child mortality. Report.
    1. 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. 2015;385(9963):117–171.
    1. Lawn J.E., Blencowe H., Oza S., You D., Lee A.C.C., Waiswa P. Every newborn: progress, priorities, and potential beyond survival. Lancet. 2014:189–205.
    1. Zaman K., Roy E., Arifeen S.E., Rahman M., Raqib R., Wilson E. Effectiveness of maternal influenza immunization in mothers and infants. N Engl J Med. 2008;359(15):1555–1564.
    1. Chu H.Y., Englund J.A. Maternal immunization. Clin Infect Dis. 2014;59(4):560–568.
    1. Blencowe H., Lawn J., Vandelaer J., Roper M., Cousens S. Tetanus toxoid immunization to reduce mortality from neonatal tetanus. Int J Epidemiol. 2010;39(Suppl. 1)
    1. Swamy G.K., Phillips Heine R. Clinical Expert Series. Vaccinations for pregnant women. Obstet Gynecol. 2015;125(1):212–226.
    1. Swamy G.K., Wheeler S.M. Neonatal pertussis, cocooning and maternal immunization. Expert Rev Vaccines. 2014;13(9):1107–1114.
    1. Keller-Stanislawski B., Englund J.A., Kang G., Mangtani P., Neuzil K., Nohynek H. Safety of immunization during pregnancy: a review of the evidence of selected inactivated and live attenuated vaccines. Vaccine. 2014;32(52):7057–7064.
    1. Tamma P.D., Ault K.A., del Rio C., Steinhoff M.C., Halsey N.A., Omer S.B. Safety of influenza vaccination during pregnancy. Am J Obstet Gynecol. 2009;201(6):547–552.
    1. Munoz F.M., Weisman L.E., Read J.S., Siberry G., Kotloff K., Friedman J. Assessment of safety in newborns of mothers participating in clinical trials of vaccines administered during pregnancy. Clin Infect Dis. 2014;59(Suppl. 7):S415–S427.
    1. WHO, Brighton Collaboration . 2014. WHO Meeting to develop Brighton Collaboration definitions of key terms used for monitoring the safety of immunization in pregnancy in mothers and newborn children; pp. 24–25.
    1. Kohl K.S., Gidudu J., Bonhoeffer J., Braun M.M., Buettcher M., Chen R.T. The development of standardized case definitions and guidelines for adverse events following immunization. Vaccine. 2007;25(31):5671–5674.
    1. Donegan K., King B., Bryan P. Safety of pertussis vaccination in pregnant women in UK: observational study. BMJ. 2014;349(1):g4219.
    1. Dodds L., Macdonald N., Scott J., Spencer A., Allen V.M., McNeil S. The association between influenza vaccine in pregnancy and adverse neonatal outcomes. J Obstet Gynaecol Can. 2012;34(8):714–720.
    1. Legge A., Dodds L., MacDonald N.E., Scott J., McNeil S. Rates and determinants of seasonal influenza vaccination in pregnancy and association with neonatal outcomes. CMAJ. 2014;186(4):E157–E164.
    1. Oram J., Murphy P. Diagnosis of death. Contin Educ Anaesth Crit Care Pain. 2011;11(3):77–81.
    1. Rubinstein F., Micone P., Bonotti A., Wainer V., Schwarcz A., Augustovski F. Influenza A/H1N1 MF59 adjuvanted vaccine in pregnant women and adverse perinatal outcomes: multicentre study. BMJ. 2013;346(1):f393.
    1. Cleary B.J., Rice Ú., Eogan M., Metwally N., McAuliffe F. 2009 A/H1N1 influenza vaccination in pregnancy: uptake and pregnancy outcomes – a historical cohort study. Eur J Obstet Gynecol Reprod Biol. 2014;178:163–168.
    1. Barfield W.D. Standard terminology for fetal, infant, and perinatal deaths. Pediatrics. 2011;128(1):177–181.
    1. World Health Organization . vol. 2. 2011. p. 195. (International Classification of Diseases (ICD). Instruction Manual. 6 Classifications).
    1. Fell D., Platt R., Lanes A., Wilson K., Kaufman J., Basso O. Fetal death and preterm birth associated with maternal influenza vaccination: systematic review. BJOG. 2015;122(1):17–26.
    1. Fell D.B., Sprague A.E., Liu N., Yasseen A.S., Wen S.-W., Smith G. H1N1 influenza vaccination during pregnancy and fetal and neonatal outcomes. Am J Public Health. 2012;102(6):e33–e40.
    1. Ryan M.A.K., Gumbs G.R., Conlin A.M.S., Sevick C.J., Jacobson I.G., Snell K.J. Evaluation of preterm births and birth defects in liveborn infants of US military women who received smallpox vaccine. Birth Defects Res A Clin Mol Teratol. 2008;82(7):533–539.
    1. Harjulehto-mervaala T., Aro T., Hiilesmaa V.K., Hovi T., Saxen H., Saxen L. Oral polio vaccination during pregnancy: lack of impact on fetal development and perinatal outcome. Clin Infect Dis. 1986:414–420.
    1. Nordin J.D., Kharbanda E.O., Vazquez Benitez G., Lipkind H., Vellozzi C., DeStefano F. Maternal influenza vaccine and risks for preterm or small for gestational age birth. J Pediatr. 2014;164(5):1051–1057.e2.
    1. Brighton Collaboration PBWG . 2016. Preterm birth: case definition & guidelines for data collection, analysis, and presentation of immunisation safety data; pp. 1–34.
    1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Safety Pharmacology Studies For Human pharmaceuticals S7A Current Step 4 version, dated 8 November 2000, Available from: [cited 30.09.15].
    1. CIOMS Reporting adverse drug reactions: definitions of terms and criteria for their use. South Med J. 2000;102(4):345.
    1. Schulz K.F., Altman D.G., Moher D., Group C. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8(1):18.
    1. Moher D., Cook D.J., Eastwood S., Olkin I., Rennie D., Stroup D.F. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Lancet. 1999;354:1896–1900.
    1. Stroup D.F., Berlin J.A., Morton S.C., Olkin I., Williamson G.D., Rennie D. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis of Observational Studies in Epidemiology (MOOSE) group. JAMA. 2000;283(15):2008–2012.

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