Maternal and perinatal characteristics associated with Respiratory Tract Infection (RTI) healthcare utilisation and death in a birth cohort using the CPRD database and other linked databases

Date of ISAC Approval: 
Lay Summary: 
Respiratory Syncytial Virus (RSV) causes respiratory infections in young children, such as bronchitis (infection of the airways of the lungs resulting in cough, sore throat, phlegm), bronchiolitis or pneumonia. The symptoms can be mild or severe. Some risk factors associated with the disease in young children are already known, such as prematurity (born before 37 gestational weeks) and comorbidities such as congenital heart disease or Down syndrome. However, there are still some uncertainties in relation to maternal and pre-birth risk factors such as maternal smoking, type of delivery, breastfeeding status, birthweight, APGAR score (5 mins), mechanical ventilation, and oxygen use. This research aims to understand which maternal and pre-birth characteristics could increase the risk of developing the disease in early childhood. This research will use data already collected and available in the Clinical Practice Research Datalink (CPRD) linked to hospital admission, maternity and death records. The results of the research will be published and presented at medical conferences.
Technical Summary: 
Respiratory Syncytial Virus (RSV) is the most important cause of viral lower respiratory tract illness in young children worldwide and considered one of the world's greatest unmet vaccine needs. However, current knowledge on the disease is too sparse to underpin evidence-based decision-making on new RSV prevention strategies and therapeutics. Identifying the maternal and perinatal characteristics (such as maternal smoking, type of delivery, breastfeeding status, birthweight, APGAR score (5 mins), mechanical ventilation, and oxygen use) associated with Respiratory Tract Infection (RTI) healthcare utilisation (hospitalisation, outpatient visit, and GP consultation) and death likely due to RSV is key to increasing understanding of the disease. This objective will be assessed through analysis of data collected in CPRD, linked to Hospital Episode Statistics (HES), pregnancy register, Baby Mother Link, and Office for National Statistics (ONS) death registration data. The study will use a retrospective cohort of all patients eligible for linkage with HES/ONS data born between 2010 and 2015. We will compare the exposed group of patients with associated RTI healthcare utilisation or death (all events, those coded as being due to RSV, and those occurred within the RSV season), relative to the unexposed group of patients without RTI within their 2 years of follow-up. Univariate and multivariate logistic models will be conducted to assess the impact of perinatal and maternal characteristics on RTI profile, and to adjust for other relevant variables e.g. demographics, socio-economics status, and risk conditions.
Health Outcomes to be Measured: 
GP consultations for RTI; Hospitalisation for RTI; Outpatient visits for RTI; Death with RTI as cause; Maternal characteristics; Perinatal characteristics; Demographics; Comorbidities

Caroline Amand - Chief Investigator - Sanofi UK
Clarisse Demont - Collaborator - Sanofi Pasteur MSD
Harry Campbell - Collaborator - University Of Edinburgh
Rachel Reeves - Collaborator - University Of Edinburgh
Sabine Tong - Corresponding Applicant - Sanofi-aventis Recherche & Développeme

HES Admitted;HES Outpatient;Mother Baby Link;ONS;Patient IMD;Pregnancy Register