Aims To develop a family acceptable study protocol and establish the feasibility of creating a UK wide cohort of infants with Down’s syndrome (DS) to study the associations between early infant feeding, infections and the development of autoimmunity in Down’s syndrome. We hypothesise that in infants with DS already at increased risk of autoimmunity, early feeding practices may be related to the development of autoimmunity.
Method Babies with Down’s syndrome under the age of 8 months are recruited by community paediatricians and neonatologists or through flyers sent out by the Down’s Syndrome Association (DSA) and Down’s Syndrome Scotland. Parents also join the study having seen adverts on social media and relevant websites.
Parents complete feeding and medical questionnaires either online or on paper close to birth, at 6months, 12 months and yearly thereafter until the age of 5 years. They also collect a mouth swab for DNA, a stool sample from mother and baby for gut microbiome, a urine sample for urinary c peptide and a heel prick blood sample for autoantibodies close to birth. Further blood, urine and stool samples are collected at 6 months, 12 months and yearly thereafter.
Results Over 130 primary and secondary care sites across the UK have approved the study. Over a 12 month period 25 participants have been recruited having initially aimed for 100 per year. The initial questionnaire has been completed online by 19 participants (1 completed the paper questionnaire). Using kits which are sent out 17 families have successfully collected mouth swab, urine and stool samples at home. We have coordinated blood collection with participant’s routine appointments and have initial blood samples for 14.
Conclusion Recruitment of newborn babies with Down’s syndrome is challenging and has required the use of a number of recruitment methods. The use of online questionnaires has been popular and shows this to be a feasible method for data collection. Collection of mouth swab, urine and stool samples by families at home has been successful. Ongoing recruitment, data collection and assessment of the methods used in this cohort study will inform us as to the overall feasibility of FADES.
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