BPSU study - Herpes simplex virus

BPSU surveillance of neonatal herpes simplex virus disease in infants less than 90 days of ages commenced in July 2019 and will run for two years. This study will assess the current disease burden of HSV to inform future practice on detection, prevention and management of this dangerous disease.

Lead investigator

Dr Katy Fidler
Royal Alexandra Children's Hospital
Eastern Road
Brighton BN2 5BE
Email: k.fidler@bsms.ac.uk

About the study

Neonatal herpes simplex virus (HSV) disease is a devastating condition which can lead to significant morbidity and death.1 Although it is rare, we know that sexually transmitted herpes infections have increased in the last decade, and we suspect that the number of cases of neonatal herpes is therefore increasing. We also know that the number of cases increased in the UK from the first national (BPSU) study (1986-1991) to the second (2004-2006).2 A recent local study from Nottingham3 showed rates ten times higher than the first BPSU study, and served as a reminder of the devastating consequences of the disease.

At the moment we do not have enough information about the number of cases of this disease, which babies are most at risk, ways we might be able to reduce those risks and whether the treatment and prophylaxis we are using is reducing long term problems and later relapses.

In the decade since the last national UK surveillance there have been significant changes in the way we detect the virus, how common the virus may be in the adult population and how we manage both pregnant women and babies who are affected. There is a lack of clarity as to the optimum management, and advice, for mothers and babies who are at risk, and for the clinicians caring for them. There are a number of different guidelines and management strategies available for clinicians to follow. This results in variation in practice across sites.

This is of specific relevance to neonates presenting to the emergency department with possible bacterial or viral sepsis. Currently not all babies are treated for HSV; however, if the prevalence of HSV has increased nationwide to the prevalence seen in Nottingham, this may need to be considered.

You can download the protocol card, including references, below.

Case definition

  1. Any infant under 90 days of age with a diagnosis of HSV infection based on virus detection by culture, polymerase chain reaction (PCR), immunofluorescene (IF), or serology.
  2. Any infant under 90 days of age that has received a completed course of aciclovir for suspected HSV infection, where no other pathogen was found.
  3. Any stillborn infant in whom HSV is confirmed.

Reporting instructions

Please report any cases seen within the last month which meet the case definition.

Duration

July 2019 to July 2021 (25-months of surveillance). Follow up until July 2022 (1-year follow-up).

Funding

This study is funded by the Rockinghorse Children's Charity and by the Kit Tarka Foundation.

Approval

The study has been approved by Wales Research Ethics Committee 7 (reference: 19/WA/0066); HRA Confidentiality Advisory Group (reference: 19/CAG/0077); and Public Benefit and Privacy Panel for Health and Social Care (PBPP) approval in Scotland is forthcoming.

Privacy notice

Brighton and Sussex Medical School (University of Sussex) is the sponsor for this research study and Brighton and Sussex University Hospitals NHS Trust (BSUH) is the data controller for this research study - see BSUH’s privacy notice. The Data Protection Officer at BSUH can be contacted on 01444 441 881 ext 517.

The study team at Brighton and Sussex Medical School will use information from medical records for medical research. We will collect information about children with a new diagnosis of HSV from the doctors who are looking after them. Doctors will not provide names and addresses to the study team but they will provide details like sex, ethnic group, date of birth and NHS/CHI number. Doctors will complete questionnaires using information from medical records. If you want access to the information in your child’s medical records, then you should contact your child’s NHS hospital or doctor. We cannot withdraw or remove personal information from the study as this would make the research invalid.

After the study finishes, Brighton and Sussex Medical School will securely store information for 20 years, then anonymise or destroy it. Under the EU General Data Protection Regulation, the legal basis for processing this information is for the performance of a task carried out in the public interest. You can find out how the study uses personal information by contacting Dr Katy Fidler on k.fidler@bsms.ac.uk.

If you wish to complain about the use of personal information, then you should contact the Information Commissioner's Office.

Support groups

Partners

BPSU; Brighton and Sussex University Hospitals NHS Trust; Brighton and Sussex Medical School; St George's University of London
  • 1. Fidler K, Pierce CM, Cubitt WD, et al. Could neonatal disseminated herpes simplex virus infection be treated earlier? Journal of Infection 2004; 49(2): 141-146
  • 2. British Paediatric Surveillance Unit. BPSU 21st Annual Report 2006-2007. London: British Paediatric Surveillance Unit/Royal College of Paediatrics and Child Health; 2007.
  • 3. Batra D, Davies P, Manktelow BN, Smith C The incidence and presentation of neonatal herpes in a single UK tertiary centre, 2006-2013. Arch Dis Child. 2014 Oct; 99(10):916-21.