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

被引：67

作者：

Pathirana, Jayani ^{[1
,2
,3
]}

Munoz, Flor M. ^{[4
,5
,6
]}

Abbing-Karahagopian, Victoria ^{[7
]}

Bhat, Niranjan ^{[8
]}

Harris, Tara ^{[9
]}

Kapoor, Ambujam ^{[10
]}

Keene, Daniel L. ^{[11
]}

Mangili, Alexandra ^{[12
]}

Padula, Michael A. ^{[13
,14
]}

Pande, Stephen L. ^{[15
]}

Pool, Vitali ^{[16
]}

Pourmalek, Farshad ^{[17
]}

Varricchio, Frederick

Kochhar, Sonali ^{[18
]}

Cutland, Clare L. ^{[1
,2
,3
]}

机构：

[1] Med Res Council Resp & Meningeal Pathogens Res Un, Johannesburg, South Africa

[2] Natl Res Fdn, Vaccine Preventable, Dept Sci & Technol, Pretoria, Gauteng, South Africa

[3] Univ Witwatersrand, Fac Hlth Sci, Johannesburg, South Africa

[4] Baylor Coll Med, Dept Pediat, Houston, TX 77030 USA

[5] Baylor Coll Med, Dept Mol Virol, Houston, TX 77030 USA

[6] Baylor Coll Med, Dept Microbiol, Houston, TX 77030 USA

[7] Global Clin Res & Dev Epidemiol Novartis GSK Vacc, Amsterdam, Netherlands

[8] PATH, Seattle, WA USA

[9] Publ Hlth Ontario, Immunizat & Vaccine Preventable Dis, Toronto, ON, Canada

[10] Publ Hlth Fdn India, Minist Hlth & Family Welf, Immunizat Tech Support Unit, New Delhi, India

[11] Univ Ottawa, Fac Med, Dept Pediat, Ottawa, ON K1N 6N5, Canada

[12] Tufts Univ, Sch Med, Boston, MA 02111 USA

[13] Childrens Hosp Philadelphia, Div Neonatol, Philadelphia, PA 19104 USA

[14] Univ Penn, Philadelphia, PA 19104 USA

[15] Soroti Reg Referral Hosp, Minist Hlth Uganda, Soroti, Uganda

[16] Sanofi Pasteur Inc, Swiftwater, PA USA

[17] Univ British Columbia, Sch Populat & Publ Hlth, Vancouver, BC, Canada

[18] Global Healthcare Consulting, New Delhi, India

来源：

VACCINE | 2016年 / 34卷 / 49期

关键词：

Neonatal death; Maternal immunization; Adverse event; Guidelines; Case definition; INFLUENZA VACCINATION; PREGNANCY; PRETERM; ASSOCIATION; OUTCOMES; MOTHERS; TRIALS; WOMEN; FETAL;

D O I：

10.1016/j.vaccine.2016.03.040

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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. (C) 2016 Published by Elsevier Ltd.

引用

页码：6027 / 6037

页数：11

共 50 条

[31] Congenital microcephaly: Case definition & guidelines for data collection, analysis, and presentation of safety data after maternal immunisation
DeSilva, Malini
Munoz, Flor M.
Sell, Erick
Marshall, Helen
Kawai, Alison Tse
Kachikis, Alisa
Heath, Paul
Klein, Nicola P.
Oleske, James M.
Jehan, Fyezah
Spiegel, Hans
Nesin, Mirjana
Tagbo, Beckie N.
Shrestha, Anju
Cutland, Clare L.
Eckert, Linda O.
Kochhar, Sonali
Bardaji, Azucena
VACCINE, 2017, 35 (48) : 6472 - 6482
[32] Swelling at or near injection site: Case definition and guidelines for collection, analysis and presentation of immunization safety data
Kohl, Katrin S.
Walop, Wikke
Gidudu, Jane
Ball, Leslie
Halperin, Scott
Hammer, Sandra Jo
Heath, Paul
Varricchio, Frederick
Rothstein, Edward
Schuind, Anne
Hennig, Renald
VACCINE, 2007, 25 (31) : 5858 - 5874
[33] Induration at or near injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data
Kohl, Katrin S.
Walop, Wikke
Gidudu, Jane
Ball, Leslie
Halperin, Scott
Hammer, Sandra Jo
Heath, Paul
Hennig, Renald
Rothstein, Edward
Schuind, Anne
Varricchio, Frederick
VACCINE, 2007, 25 (31) : 5839 - 5857
[34] Non-reassuring fetal status: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data
Gravett, Courtney
Eckert, Linda O.
Gravett, Michael G.
Dudley, Donald J.
Stringer, Elizabeth M.
Mujobu, Tresor Bodjick Muena
Lyabis, Olga
Kochhar, Sonali
Swamy, Geeta K.
VACCINE, 2016, 34 (49) : 6084 - 6092
[35] Vaccine-associated enhanced disease: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data
Munoz, Flor M.
Cramer, Jakob P.
Dekker, Cornelia L.
Dudley, Matthew Z.
Graham, Barney S.
Gurwith, Marc
Law, Barbara
Perlman, Stanley
Polack, Fernando P.
Spergel, Jonathan M.
Van Braeckel, Eva
Ward, Brian J.
Didierlaurent, Arnaud M.
Lambert, Paul Henri
VACCINE, 2021, 39 (22) : 3053 - 3066
[36] Acute respiratory distress syndrome (ARDS) as an adverse event following immunization: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data
Serazin, Nathan A.
Edem, Bassey
Williams, Sarah R.
Ortiz, Justin R.
Kawade, Anand
Das, Manoj Kumar
Subelj, Maja
Edwards, Kathryn M.
Parida, Shreemanta K.
Wartel, T. Anh
Munoz, Flor M.
Bastero, Patricia
VACCINE, 2021, 39 (22) : 3028 - 3036
[37] Hypertensive disorders of pregnancy: Case definitions & guidelines for data collection, analysis, and presentation of immunization safety data
Rouse, Caroline E.
Eckert, Linda O.
Wylie, Blair J.
Lyell, Deirdre J.
Jeyabalan, Arundhathi
Kochhar, Sonali
McElrath, Thomas F.
VACCINE, 2016, 34 (49) : 6069 - 6076
[38] Preterm birth: Case definition & guidelines for data collection, analysis, and presentation of immunisation safety
Quinn, Julie-Anne
Munoz, Flor M.
Gonik, Bernard
Frau, Lourdes
Cutland, Clare
Mallett-Moore, Tamala
Kissou, Aimee
Wittke, Frederick
Das, Manoj
Nunes, Tony
Pye, Savia
Watson, Wendy
Ramos, Ana-Maria Alguacil
Cordero, Jose F.
Huang, Wan-Ting
Kochhar, Sonali
Buttery, Jim
VACCINE, 2016, 34 (49) : 6047 - 6056
[39] Robust take following exposure to vaccinia virus: Case definition and guidelines of data collection, analysis, and presentation of immunization safety data
Graham, Philip L.
LaRussa, Philip S.
Kohl, Katrin S.
VACCINE, 2007, 25 (31) : 5763 - 5770
[40] A local reaction at or near injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data
Gidudu, Jane
Kohl, Katrin S.
Halperin, Scott
Harnmer, Sandra Jo
Heath, Paul T.
Hennig, Renald
Hoet, Bernard
Rothstein, Edward
Schuind, Anne
Varricchioi, Frederick
Walop, Wikke
VACCINE, 2008, 26 (52) : 6800 - 6813

← 1 2 3 4 5 →