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

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Vaccine. 2016 Jul 19. pii: S0264-410X(16)30023-8. doi: 10.1016/j.vaccine.2016.03.040. [Epub ahead of print]

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

Pathirana J¹, Muñoz FM², Abbing-Karahagopian V³, Bhat N⁴, Harris T⁵, Kapoor A⁶, Keene DL⁷, Mangili A⁸, Padula MA⁹, Pande SL¹⁰, Pool V¹¹, Pourmalek F¹², Varricchio F¹³, Kochhar S¹⁴, Cutland CL¹⁵; Brighton Collaboration Neonatal Death Working Group.

Author information

• ¹Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Johannesburg, South Africa; Department of Science and Technology, National Research Foundation, Vaccine Preventable Diseases, South Africa; Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
• ²Departments of Pediatrics, Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.
• ³Global Clinical Research & Development - Epidemiology Novartis/GSK Vaccines, Amsterdam, The Netherlands.
• ⁴Program for Appropriate Technology in Health (PATH), Seattle, USA.
• ⁵Immunization and Vaccine Preventable Diseases, Public Health Ontario, Canada.
• ⁶Immunization Technical Support Unit - Ministry of Health and Family Welfare, Public Health Foundation of India, New Delhi, India.
• ⁷Department of Pediatrics, Faculty of Medicine, University of Ottawa, Ontario, Canada.
• ⁸Tufts University School of Medicine, Boston, MA, USA.
• ⁹Division of Neonatology, The Childrens Hospital of Philadelphia and University of Pennsylvania, USA.
• ¹⁰Ministry of Health Uganda, Soroti Regional Referral Hospital, Uganda.
• ¹¹Sanofi Pasteur Inc., Swiftwater, PA, USA.
• ¹²School of Population and Public Health, University of British Columbia, Vancouver, Canada.
• ¹³Independent Consultant, Vaccinologist, USA.
• ¹⁴Global Healthcare Consulting, New Delhi, India.
• ¹⁵Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Johannesburg, South Africa; Department of Science and Technology, National Research Foundation, Vaccine Preventable Diseases, South Africa; Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: contact@brightoncollaboration.org.

Abstract below; full text is at http://www.sciencedirect.com/science/article/pii/S0264410X16300238

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.

Copyright © 2016. Published by Elsevier Ltd.

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