Preterm birth: Case definition & guidelines for data collection, analysis, and presentation of immunisation safety data
Preterm birth is commonly defined as any birth before 37 weeks completed weeks of gestation. An estimated 15 million infants are born preterm globally, disproportionately affecting low and middle income countries (LMIC). It contributes directly to estimated one million neonatal deaths annually and i...
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| Published in | Vaccine Vol. 34; no. 49; pp. 6047 - 6056 |
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| Main Authors | , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Netherlands
Elsevier Ltd
01.12.2016
Elsevier Limited Elsevier Science |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Preterm birth is commonly defined as any birth before 37 weeks completed weeks of gestation. An estimated 15 million infants are born preterm globally, disproportionately affecting low and middle income countries (LMIC). It contributes directly to estimated one million neonatal deaths annually and is a significant contributor to childhood morbidity. However, in many clinical settings, the information available to calculate completed weeks of gestation varies widely. Accurate dating of the last menstrual period (LMP), as well as access to clinical and ultrasonographic evaluation are important components of gestational age assessment antenatally. This case definition assign levels of confidence to categorisation of births as preterm, utilising assessment modalities which may be available across different settings. These are designed to enable systematic safety evaluation of vaccine clinical trials and post-implementation programmes of immunisations in pregnancy. |
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| AbstractList | Preterm birth is commonly defined as any birth before 37 weeks completed weeks of gestation. An estimated 15 million infants are born preterm globally, disproportionately affecting low and middle income countries (LMIC). It contributes directly to estimated one million neonatal deaths annually and is a significant contributor to childhood morbidity. However, in many clinical settings, the information available to calculate completed weeks of gestation varies widely. Accurate dating of the last menstrual period (LMP), as well as access to clinical and ultrasonographic evaluation are important components of gestational age assessment antenatally. This case definition assign levels of confidence to categorisation of births as preterm, utilising assessment modalities which may be available across different settings. These are designed to enable systematic safety evaluation of vaccine clinical trials and post-implementation programmes of immunisations in pregnancy. Abstract Preterm birth is commonly defined as any birth before 37 weeks completed weeks of gestation. An estimated 15 million infants are born preterm globally, disproportionately affecting low and middle income countries (LMIC). It contributes directly to estimated one million neonatal deaths annually and is a significant contributor to childhood morbidity. However, in many clinical settings, the information available to calculate completed weeks of gestation varies widely. Accurate dating of the last menstrual period (LMP), as well as access to clinical and ultrasonographic evaluation are important components of gestational age assessment antenatally. This case definition assign levels of confidence to categorisation of births as preterm, utilising assessment modalities which may be available across different settings. These are designed to enable systematic safety evaluation of vaccine clinical trials and post-implementation programmes of immunisations in pregnancy. |
| Author | Huang, Wan-Ting Mallett-Moore, Tamala Cutland, Clare Frau, Lourdes Das, Manoj Nunes, Tony Gonik, Bernard Ramos, Ana-Maria Alguacil Quinn, Julie-Anne Buttery, Jim Kissou, Aimee Watson, Wendy Wittke, Frederick Cordero, Jose F. Kochhar, Sonali Munoz, Flor M. Pye, Savia |
| AuthorAffiliation | f Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Department of Science and Technology National Research Foundation, Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa l Communicable Disease Prevention and Control, Nova Scotia, Canada n Dirección General de Salud Pública, Avd Cataluña n°21, 46020 Valencia, Spain q Global Healthcare Consulting, India i Debiopharm International SA, Lausanne, Switzerland a SAEFVIC, Murdoch Childrens Research Institute, Victoria, Australia k Optum Epidemiology, Providence, RI, USA p Taiwan Centers for Disease Control, Taipei, Taiwan g Global Pharmacovigilance, Sanofi Pasteur, Swiftwater, Philadelphia, USA c Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA m Pfizer Inc, Collegeville, PA, USA e LMF Pharmacoepidemiology, New York, USA j INCLEN Trust International, India b Infection and Immunity, Monash Children's Ho |
| AuthorAffiliation_xml | – name: n Dirección General de Salud Pública, Avd Cataluña n°21, 46020 Valencia, Spain – name: q Global Healthcare Consulting, India – name: i Debiopharm International SA, Lausanne, Switzerland – name: j INCLEN Trust International, India – name: a SAEFVIC, Murdoch Childrens Research Institute, Victoria, Australia – name: d Department of Obstetrics and Gynecology, Wayne State University, Detroit, MI, USA – name: c Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA – name: p Taiwan Centers for Disease Control, Taipei, Taiwan – name: h Department of Pediatrics, Souro Sanou Teaching Hospital, Bobo-Dioulasso, Burkina Faso – name: o University of Puerto Rico Graduate School of Public Health, Medical Sciences Campus, San Juan 00935, Puerto Rico – name: l Communicable Disease Prevention and Control, Nova Scotia, Canada – name: e LMF Pharmacoepidemiology, New York, USA – name: k Optum Epidemiology, Providence, RI, USA – name: m Pfizer Inc, Collegeville, PA, USA – name: f Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Department of Science and Technology National Research Foundation, Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa – name: b Infection and Immunity, Monash Children's Hospital, Department of Paediatrics, The Ritchie Centre, Hudson Institute, Monash University, Australia – name: g Global Pharmacovigilance, Sanofi Pasteur, Swiftwater, Philadelphia, USA |
| Author_xml | – sequence: 1 givenname: Julie-Anne surname: Quinn fullname: Quinn, Julie-Anne organization: SAEFVIC, Murdoch Childrens Research Institute, Victoria, Australia – sequence: 2 givenname: Flor M. surname: Munoz fullname: Munoz, Flor M. organization: Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA – sequence: 3 givenname: Bernard surname: Gonik fullname: Gonik, Bernard organization: Department of Obstetrics and Gynecology, Wayne State University, Detroit, MI, USA – sequence: 4 givenname: Lourdes surname: Frau fullname: Frau, Lourdes organization: LMF Pharmacoepidemiology, New York, USA – sequence: 5 givenname: Clare surname: Cutland fullname: Cutland, Clare organization: Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Department of Science and Technology National Research Foundation, Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa – sequence: 6 givenname: Tamala surname: Mallett-Moore fullname: Mallett-Moore, Tamala organization: Global Pharmacovigilance, Sanofi Pasteur, Swiftwater, Philadelphia, USA – sequence: 7 givenname: Aimee surname: Kissou fullname: Kissou, Aimee organization: Department of Pediatrics, Souro Sanou Teaching Hospital, Bobo-Dioulasso, Burkina Faso – sequence: 8 givenname: Frederick surname: Wittke fullname: Wittke, Frederick organization: Debiopharm International SA, Lausanne, Switzerland – sequence: 9 givenname: Manoj surname: Das fullname: Das, Manoj organization: INCLEN Trust International, India – sequence: 10 givenname: Tony surname: Nunes fullname: Nunes, Tony organization: Optum Epidemiology, Providence, RI, USA – sequence: 11 givenname: Savia surname: Pye fullname: Pye, Savia organization: Communicable Disease Prevention and Control, Nova Scotia, Canada – sequence: 12 givenname: Wendy surname: Watson fullname: Watson, Wendy organization: Pfizer Inc, Collegeville, PA, USA – sequence: 13 givenname: Ana-Maria Alguacil surname: Ramos fullname: Ramos, Ana-Maria Alguacil organization: Dirección General de Salud Pública, Avd Cataluña n°21, 46020 Valencia, Spain – sequence: 14 givenname: Jose F. surname: Cordero fullname: Cordero, Jose F. organization: University of Puerto Rico Graduate School of Public Health, Medical Sciences Campus, San Juan 00935, Puerto Rico – sequence: 15 givenname: Wan-Ting surname: Huang fullname: Huang, Wan-Ting organization: Taiwan Centers for Disease Control, Taipei, Taiwan – sequence: 16 givenname: Sonali surname: Kochhar fullname: Kochhar, Sonali organization: Global Healthcare Consulting, India – sequence: 17 givenname: Jim surname: Buttery fullname: Buttery, Jim email: contact@brightoncollaboration.org organization: SAEFVIC, Murdoch Childrens Research Institute, Victoria, Australia |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/27743648$$D View this record in MEDLINE/PubMed |
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| Snippet | Preterm birth is commonly defined as any birth before 37 weeks completed weeks of gestation. An estimated 15 million infants are born preterm globally,... Abstract Preterm birth is commonly defined as any birth before 37 weeks completed weeks of gestation. An estimated 15 million infants are born preterm... |
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| SubjectTerms | Adverse event Age Allergy and Immunology Antenatal Babies Case definition childhood clinical trials Clinical Trials as Topic Collaboration Data collection Female gestational age Guidelines Humans Immunisation Immunization Immunization - adverse effects income Infant Infant Mortality Infant, Newborn Infant, Premature infants Menstruation Methods Morbidity Poverty Pregnancy Premature Birth Preterm birth Statistics as Topic Surveillance ultrasonography vaccines |
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| Title | Preterm birth: Case definition & guidelines for data collection, analysis, and presentation of immunisation safety data |
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