Infant CMV Study
Research type
Research Study
Full title
CMV Interferon Gamma Release Assays (IGRA); a tool for monitoring treatment in infants with CMV in the first year of life
IRAS ID
243371
Contact name
Elizabeth Whittaker
Contact email
Sponsor organisation
Imperial College
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Cytomegalovirus(CMV), is a virus that poses serious risks to unborn babies. Infection before birth is one of the leading causes of hearing loss in children and can result in poor neurodevelopmental outcomes. CMV in preterm infants also results in severe disease. \nAnti-viral treatment is recommended for babies with severe CMV infections and can prevent neurological damage. The goal of treatment is to reduce the amount of active virus until the baby is able to control the infection with her own immune system. New blood tests, CMV IGRA (commercial tests include CMV ELISpot and Quantiferon), measure the immune response to CMV, and could potentially identify which infants would benefit from treatment, as well as the optimal duration of treatment, potentially limiting side-effects. \nStudy Aims:\n1.-To describe the evolution of CMV IGRA results in infants with CMV receiving treatment. \n2.-To define the clinical burden of CMV infection in preterm infants, and investigate a relationship between outcome and CMV IGRA results \n3.-To explore whether distinctive CMV strains are associated with more severe disease manifestations\n4. To describe ’normal’ CMV IGRA results in healthy infants without CMV infection\nThis study will result in improved clinical care of infants with CMV infection. It will also improve our understanding of the progression of CMV infections in preterm infants.\nThe healthy control group will be recruited from phlebotomy (blood sampling) clinics/pre-surgical screening clinics at St Marys Hospital. Infants with CMV infection will be recruited both from the paediatric outpatient department at St. Marys Hospital and the neonatal units (St. Marys and Queen Charlottes) at Imperial Healthcare NHS Trust.
REC name
London - Hampstead Research Ethics Committee
REC reference
18/LO/0379
Date of REC Opinion
27 Feb 2018
REC opinion
Favourable Opinion