Influenza & COVID Obstetric and Perinatal Epidemiology Study in India

流感

基本信息

批准号：
10709550
负责人：
Patricia L Hibberd
金额：
$ 53.5万
依托单位：
BOSTON UNIVERSITY MEDICAL CAMPUS
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-23 至 2027-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10709550
关键词：
2019-nCoV Acute-Phase Proteins Address Admission activity Antibodies Biological Markers Birth Birth Weight Blood COVID-19 COVID-19 impact COVID-19 patient COVID-19 risk COVID-19 severity Centers for Disease Control and Prevention (U.S.)Child China Cohort Studies Collaborations Collection Communicable Diseases Country Critical Illness Data Discipline of obstetrics Disease Dryness Emergency Situation Enrollment Fetus First Pregnancy Trimester Funding Future Hospitalization Hospitals Immune response Immunoglobulin G Immunoglobulin M Incidence Income India Infection Inflammatory Influenza Intensive Care Investigation Joints Laboratories Late pregnancy Life Maternal Mortality Mediating Mediator Mothers National Institute of Child Health and Human Development Neonatal Newborn Infant Observational Study Outcome Pattern Perinatal Epidemiology Perinatal mortality demographics Polymerase Chain Reaction Positioning Attribute Postpartum Period Pre-Eclampsia Pregnancy Pregnancy loss Pregnant Women Premature Birth Premature Labor Prevalence Prevention Province Public Health Publications Readiness Reporting Resource-limited setting Respiratory Signs and Symptoms Reverse Transcription Risk Risk Factors SARS-CoV-2 infection Severities Site Specimen Spottings Symptoms Tablets Testing Time Update Vaccination Vaccines Visit Woman antenatal care asymptomatic COVID-19 at-risk pregnancies biobank breakthrough infection cohort coronavirus disease cytokine epidemiology study experience fetal follow-up influenza infection low and middle-income countries maternal outcome maternal risk mortality nasopharyngeal swab neonate offspring perinatal outcomes primary outcome recruit respiratory infection virus respiratory virus seasonal influenza secondary analysis stillbirth symptomatic COVID-19 ultrasound variants of concern

项目摘要

Coronavirus disease 2019 (COVID-19) caused by Severe Acute Respiratory Syndrome Corona Virus 2 (SARS- CoV-2) was first reported in Wuhan, Hubei Province of China in December 2019 and by early 2021, there have been more than 100 million cases of COVID-19 globally. The consequences of COVID-19 in pregnant women in high/upper middle-income countries are under intensive investigation. There are few parallel studies in low/lower middle- income countries (LMIC) and data on COVID-19 infection in high-income countries may not be generalizable to LMIC. Given the large number of the world’s births that occur in LMIC, there is an urgent need to understand the risk of COVID-19 (and other respiratory viruses (ORV), particularly influenza) to pregnant women and newborns. Our group recently led the Indian site of the Centers for Disease Control and Prevention study on the impact of laboratory confirmed influenza in pregnant women in 3 LMICs, finding that influenza was associated with late pregnancy loss and reduced mean birthweight. Leveraging this recently completed study and 10 years of experience of studying ~10,000 pregnant women a year in Central India, we now propose the “Influenza & COVID Obstetric and Perinatal Epidemiology (ICOPE) Study in India.” ICOPE will enrol 10,000 pregnant women presenting to a large obstetric hospital in Nagpur, India for antenatal care. Important features of our study include: (i) documented ability to recruit women in the first trimester of pregnancy (ultrasound confirmed); (ii) twice weekly follow-up for COVID-19/ORV/Influenza symptoms, combined with laboratory testing for symptomatic and asymptomatic infection (reverse transcription–polymerase chain reaction testing of nasopharyngeal swabs and frequent collection of dried blood spots for COVID IgG and IgM) during pregnancy through day 7 post-partum. Neonates with critical illness will be assessed for COVID-19 and influenza and dried blood spots will be obtained for COVID antibodies on day 7 of life. Pregnant women admitted with COVID-19 will have specimens obtained to evaluate trajectories of inflammatory cytokines. We will biobank dried blood spots for future studies. Our specific aims are to: (1) determine the prevalence, incidence and maximal severity of symptomatic or asymptomatic COVID-19 in pregnant women to day 7 postpartum and whether influenza/ORV infection or vaccination modifies and pre-term birth mediates this risk; (2) determine the effect of maternal COVID-19 infection on the fetus and/or neonate to day 7 of life; and whether influenza/ORV or vaccination modifies and pre-term birth mediates this risk; (3) characterize patterns and trajectories of host response/inflammatory biomarkers as potential mediators of COVID-19±influenza infection on progression to severe illness in pregnant women/mothers admitted with COVID-19. Modifiers include vaccination. ICOPE is well positioned to provide information on the impact of COVID-19 and ORV, across all trimesters, over time in a LMIC setting.

加冕病毒疾病2019（COVID-19）由严重急性呼吸道综合症病毒2（SARS- COV-2）于2019年12月在中国湖北省的武汉报道，到2021年初，我们在全球范围内超过1亿案。 Covid-19孕妇的后果在高/上层收入中，国家正在投资密集。很少有平行研究低收入国家/地区的低/下中等收入国家（LMIC）和高收入国家的COVID-19 可以推广到LMIC。鉴于LMIC发生的世界大量出生，有一个紧急的需要了解孕妇的Covid-19（以及其他呼吸道病毒（ORV），尤其影响）的风险妇女和新生儿。我们的小组最近领导了印度疾病控制与预防中心的地点研究实验室影响的研究证实了3个LMIC孕妇的影响力，发现流感是与晚期妊娠丧失和平均出生体重减少有关。利用这项最近完成的研究以及在印度中部每年研究约10,000名孕妇的10年经验，我们现在建议 “印度的流感和共同产科和围产期流行病学（ICOPE）研究。” ICOPE将注册10,000 孕妇在印度那格浦尔的一家大型产科医院出庭接受天内护理。重要功能我们的研究包括：（i）在怀孕的头三个月招募妇女的能力（超声确认的）; （ii）Covid-19/ORV/流感症状的每周两次随访，结合实验室测试有症状和不对称感染（逆转录 - 聚合酶链链反应测试怀孕期间，鼻咽拭子和经常收集Covid IgG和IgM的干血点在第7天，后方。将对Covid-19和actractza进行评估患有危重疾病的新生儿并干燥在生命的第7天，将获得用于共证抗体的血斑。孕妇接受了Covid-19 将获得标本以评估炎症细胞因子的轨迹。我们将生物库干血未来研究的景点。我们的具体目的是：（1）确定患病率，事件和最大严重性在产后第7天的孕妇中有症状或不对称的互联-19 感染或疫苗修饰并预期出生介导了这种风险；（2）确定母亲的影响胎儿和/或新生儿的感染到生命的第7天；以及影响力/ORV还是疫苗接种修改和术前出生介导了这种风险；（3）表征主机的模式和轨迹反应/炎症生物标志物作为COVID-19±流感感染的潜在介体在进展中孕妇/母亲的严重疾病接受了Covid-19。修饰符包括疫苗接种。 Icope是随着时间的流逝 LMIC设置。