Estimation of background rates of adverse events of special interest in neonatal outcomes: preterm births, stillbirths, neonatal deaths and low birthweight
Loading...
Date
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
World Health Organization
Abstract
Description
vii, 66 p.
Robust baseline data on neonatal outcomes are essential for strengthening vaccine safety surveillance and informing maternal immunization policies, particularly in settings with high perinatal mortality. This document presents a WHO master protocol designed to estimate background rates of selected adverse events of special interest (AESIs) in neonatal outcomes, including preterm birth, stillbirth, neonatal death and low birthweight. It situates the need for such data within the expansion of maternal vaccination programmes and the requirement to establish pre-introduction reference rates for safety monitoring in low- and middle-income countries (LMICs). The protocol outlines a multisite prospective cohort study conducted in selected sentinel health facilities, using standardized case definitions developed by the Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) initiative. It describes study design, population and data collection procedures, including follow-up of newborns up to 28 days of life to ascertain outcomes. The methodology specifies the use of denominator data to calculate rates and proportions, with analyses stratified by site, country and key maternal and neonatal characteristics. The document further addresses ethical considerations, data management and implementation arrangements, emphasizing adaptability for country-specific use. Intended for national authorities, researchers and pharmacovigilance practitioners, it supports the generation of high-quality epidemiological evidence to contextualize safety signals, strengthen monitoring systems and guide decision-making in maternal and neonatal health programmes.
Robust baseline data on neonatal outcomes are essential for strengthening vaccine safety surveillance and informing maternal immunization policies, particularly in settings with high perinatal mortality. This document presents a WHO master protocol designed to estimate background rates of selected adverse events of special interest (AESIs) in neonatal outcomes, including preterm birth, stillbirth, neonatal death and low birthweight. It situates the need for such data within the expansion of maternal vaccination programmes and the requirement to establish pre-introduction reference rates for safety monitoring in low- and middle-income countries (LMICs). The protocol outlines a multisite prospective cohort study conducted in selected sentinel health facilities, using standardized case definitions developed by the Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) initiative. It describes study design, population and data collection procedures, including follow-up of newborns up to 28 days of life to ascertain outcomes. The methodology specifies the use of denominator data to calculate rates and proportions, with analyses stratified by site, country and key maternal and neonatal characteristics. The document further addresses ethical considerations, data management and implementation arrangements, emphasizing adaptability for country-specific use. Intended for national authorities, researchers and pharmacovigilance practitioners, it supports the generation of high-quality epidemiological evidence to contextualize safety signals, strengthen monitoring systems and guide decision-making in maternal and neonatal health programmes.
Keywords
Infant, Newborn, Pregnancy, Vaccination, Pharmacovigilance, Drug-Related Side Effects and Adverse Reactions, Pregnancy Complications, Premature Birth, Infant, Premature, Stillbirth, Infant Mortality, Perinatal Death, Birth Weight, Low Birth Weight, Epidemiologic Methods, Incidence, Data Collection, Data Management, Sample Size, Research Design, Ethics Committees, Research, Developing Countries, Confidentiality, Informed Consent, Computer Security, Information Dissemination, Advisory Committees, Surveys and Questionnaires, Form, Guideline, methods, adverse effects, ethics