Neonatal HSV disease in infants under 90 days of age. v1.0.
Research type
Research Study
Full title
Enhanced surveillance of neonatal herpes simplex disease in UK and Irish infants less than 90 days of age.
IRAS ID
116856
Contact name
Katy Fidler
Contact email
Sponsor organisation
Research and Enterprise Services, University of Sussex
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
3 years, 0 months, 28 days
Research summary
Herpes simplex virus (HSV) is a virus. This is very common and usually causes benign cold sores in adults. However, it can cause dangerous illness and death in newborn infants. Neonatal HSV disease is when the virus makes a baby sick in their first few days or weeks of life. This usually occurs as disseminated disease (affecting the blood) or HSV meningoencephalitis (affecting the brain). Both have a high mortality and severe consequences.
HSV can be transmitted to infants from the mother during pregnancy or delivery, or after birth from kissing or touching someone with a cold sore.
Infants who receive prompt treatment for HSV have a better outcome that those whose treatment is delayed.
The last HSV surveillance study was undertaken over 11 years ago. There are a number of reasons why the incidence of neonatal herpes, as well as its risk factors and outcomes, may have changed since then. We need to collect comprehensive information to assess the current disease burden, and inform future practice on detection, prevention and treatment of disease.
We aim to do this through a study of all cases of neonatal HSV in infants under 90 days of age in the UK and Ireland over a 2 year period. We will do this by asking paediatricians to notify us of cases of neonatal HSV as they occur via a routine reporting source called the British Paediatric Surveillance Unit. This study will follow the BPSU’s standardised protocols, ethical approval and governance which are in place for all studies such as these.
The BPSU “Orange Card” system undertakes active surveillance of a number of disorders by requesting that participating clinicians notify the BPSU of cases on a monthly basis. This process is described in detail in subsequent sections.
REC name
Wales REC 7
REC reference
19/WA/0066
Date of REC Opinion
25 Feb 2019
REC opinion
Favourable Opinion