eLIXIR Research Tissue Bank
Research type
Research Tissue Bank
IRAS ID
232428
Contact name
Angela Flynn
Contact email
Research summary
eLIXIR Research Tissue Bank/Database
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
18/EE/0120
Date of REC Opinion
25 Jun 2018
REC opinion
Further Information Favourable Opinion
Data collection arrangements
Samples and collection\nAll pregnant women when they attend for antenatal care at Guys and St Thomas’ NHS Foundation Trust (GSTFT)will be asked for permission to obtain an extra blood sample. Surplus blood from routine samples obtained from infants admitted to neonatal intensive care unit (NICU) will be collected. In the community setting, and in NICU, extra blood will be collected using a Whatman card from infants as part of the routine heel prick test performed by health care professionals.\n\nData\nMaternal and infant demographic and clinical data will be collected on a study specific internet based research computer data management system. \n\nConsent\nA member of the study team will approach women in antenatal areas at Guys and St Thomas’ NHS Foundation Trust (GSTFT) during early pregnancy regarding participation. The women will view a short animated film, specifically developed for this study, to describe the sample collection component of eLIXIR on an electronic tablet. Additionally, patient information sheets will be supplied to women to take home and consider participation, and posters will be available in all clinical areas frequented by pregnant women. \n\nWomen who agree to take part will be asked to sign a consent form for sample collection and that of their infants and will be given a copy of this to keep.
Research programme
The provision of samples from pregnant women attending antenatal care in GSTFT will provide a unique bioresource to address mechanisms of common and rarer complications in pregnancy and in neonatal life at a population level. Complications in pregnancy include, for example, gestational diabetes, pre-eclampsia and preterm birth, and some rarer outcomes such as fetal death (stillbirth) and congenital malformations and inherited childhood disorders. Similarly, we shall be able to address complications in the child eg neonatal death, problems related to prematurity eg respiratory distress syndrome and their relationship with maternal health, metabolism and interactions with maternal environmental exposures, including therapeutic drugs. We aim to achieve additional mechanistic insight through for example, evaluation of the neonatal epigenome. \n\nThis study also has the advantage over smaller cohort studies in providing a continuous collection of samples from the antenatal population and from infants, enabling identification of population trends and influences of new clinical interventions, changes in National Guidelines etc. This has benefit for clinical management as these results can be relayed to out clinical teams providing a constant source of feedback. [COVID-19 amendment 11/05/2020] We will recruit a separate sub-cohort of pregnant women (n=200) to study prenatal exposure to SARS-CoV-2 viral infection(causing covid-19).\nPrimary Object: To create a Research Tissue Bank/Database of maternal antenatal samples to be used to investigate prenatal exposure to SARS-CoV-2 viral infection (causing covid-19).\nWe will test blood samples obtained from these women at their 11-15 week ultrasound clinic to define SARS-CoV-2 seropositive and negative mothers and maternal inflammatory state. As part of the informed consent process, if these women agree to be contacted about future research, they will be contacted about participating in MR imaging\nstudies of the fetal/neonatal brain to study functional and structural brain development in the infants of seropositive and seronegative mothers. This will allow us to determine if fetal exposure\nto SARS-CoV-2 causes aberrant brain maturation and would establish a unique cohort of patients with a specific intrauterine exposure to a novel maternal viral disease. It will collect data on early and late fetal exposure together with precise and rich measures of brain development during fetal life.
Storage license
12624
RTBTitle
eLIXIR Research Tissue Bank/Database
Establishment organisation
Department of Women and Children's Health, King’s College London
Establishment organisation address
10th floor North Wing St Thomas’ Hospital
Westminster Bridge Road
London
SE1 7EH