Surveillance of Severe Microcephaly in the UK and Ireland (SSM-UKI)
Research type
Research Study
Full title
Surveillance of Severe Microcephaly in the UK and Ireland (SSM-UKI)
IRAS ID
225416
Contact name
Rachel L Knowles
Contact email
Clinicaltrials.gov Identifier
Z6364106/2017/06/90, UCL Data Protection Registration (research project)
Duration of Study in the UK
12 years, 0 months, 29 days
Research summary
Microcephaly describes a baby with a ‘small head’, who has experienced poor head growth before or after birth. This rare condition may be associated with abnormal brain structure or development, and with disability, although some babies will develop normally. Many different causes of microcephaly have been described, including genetic disorders, exposure during pregnancy to environmental toxins, certain drugs, infection or malnutrition.
There is uncertainty about the number of babies affected by microcephaly in the UK, and we also lack information about how well we care for these children. This study will find out how many UK babies are born with severe microcephaly each year (defined as a head size below the 0.4th percentile or more than 3 standard deviations below the population mean), and how seriously this affects their health and developmental outcomes, particularly problems with hearing and vision. The study will provide a better picture of the care and support these babies and their families currently receive. This will allow us to make sure the right screening, diagnosis and treatment services are available to meet the future needs of children and families. Importantly it will also provide us with a way to monitor changes in the frequency of microcephaly, for example to detect any increase due to Zika-virus infection.
The study involves undertaking surveillance throughout the UK and Ireland through the British Paediatric Surveillance Unit (BPSU), a surveillance system for paediatric rare diseases. Questionnaires will be completed by clinicians (mainly paediatricians) participating in the BPSU system, who will retrieve information from routine hospital case notes. Over 13 months, we will collect reports of any newly diagnosed babies aged under one year and then collect follow-up information when these children are one and two years of age to find out about their subsequent health and development outcomes.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
17/ES/0088
Date of REC Opinion
31 Jul 2017
REC opinion
Further Information Favourable Opinion