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

• Published in: Vaccine Vol. 34; no. 49; pp. 6027 - 6037
• Main Authors: Pathirana, Jayani, Muñoz, Flor M., Abbing-Karahagopian, Victoria, Bhat, Niranjan, Harris, Tara, Kapoor, Ambujam, Keene, Daniel L., Mangili, Alexandra, Padula, Michael A., Pande, Stephen L., Pool, Vitali, Pourmalek, Farshad, Varricchio, Frederick, Kochhar, Sonali, Cutland, Clare L.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 01.12.2016; Elsevier Limited; Elsevier Science
• Subjects: Adverse event; Allergy and Immunology; Births; Case definition; Child; children; Clinical Trials as Topic; Data Collection; death; Female; Guidelines; Humans; Immunization; Immunization - adverse effects; Infant; Infant Mortality; Infant, Newborn; Maternal immunization; Morbidity; Mortality; Mothers; Neonatal death; neonates; Perinatal Death; Pregnancy; pregnant women; Statistics as Topic; Vaccines; Vaccines - administration & dosage; Vaccines - adverse effects; viability; Womens health; Adverse event; Maternal immunization; Case definition; Neonatal death; Guidelines
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2016.03.040

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.