Neonatal Complications of Coronavirus Disease (COVID-19) Study
Coronavirus is a new virus that has come from China where it was first recognised as a causing a new infection in late 2019. The virus has crossed the world and in the UK we started to see people with the virus in February 2020. Since Coronavirus is a completely new virus no one has any immunity to it.
The information here is a short version of the full details of the study. If you wish to read a more detailed explanation about the study you can do so on the privacy notice page.
Why are we doing this study?
So far we have very little information about how the virus affects mothers and newborn babies and it is not clear how best to care for the mothers and babies affected. So far we have very little information about how babies get Coronavirus infection, whether it transmits from mothers to their babies while they are still pregnant, during labour and birth, or whether the infection occurs following birth. If we carry out research now, it will mean that we can start to give the best care to mothers and babies and the best advice to pregnant women about the effects of Coronavirus on them and their baby.
This study is one of two we are running to collect information about mothers and babies who are affected by Coronavirus and are ill. One of the studies - the UKOSS COVID-19 study- is focusing on collecting information about pregnant women and mothers who have recently given birth.The second study, described here, will focus on collecting information about newborn babies who have Coronavirus or who are born to mothers who have tested positive for Coronavirus.
This information will help us to understand:
- How babies get Coronavirus
- What happens to babies when their mother has Coronavirus
- What treatments are effective in helping babies with Coronavirus to get better
- What happens to babies in the longer term when they have been treated
How will we carry out the study?
We are carrying out the study through a system called the British Paediatric Surveillance Unit (BPSU).Each week every doctor across the UK looking after newborn babies in hospital will be asked by the BPSU if they have looked after a newborn baby with Coronavirus or whose mother has tested positive for Coronavirus. If they have, they will be sent a questionnaire to collect information about the baby and their mother.
What information will we collect?
We will collect medical information about the mother, her baby and the care provided. We will also collect identifiable information about the mother and her baby so that we can link the information we collect to other data about Coronavirus. By identifiable we mean this will include the following pieces of information:
| Identifiable information | The reason we need this information |
|---|---|
| For the baby: | |
| NHS/CHI Number | So we can make sure that babies are not included in the study more than once and we can link to other information we have about Coronavirus |
| Date of Birth | So we can identify how old the baby was when they were diagnosed with COVID-19 which will indicate the likely source of infection. |
| Sex | So we can describe the population of affected babies and see if boys are affected more than girls or vice versa |
| Partial Postcode | So we can map where in the country infections with Coronavirus have occurred |
| Ethnicity | So we can describe the population of affected babies and see if some groups of babies are affected more than others |
| Baby date of death (if relevant) | So that we know how old the baby was if they died and when they died in relation to the diagnosis of the Coronavirus infection. |
| For the mother: | |
| NHS/CHI/HSCN number | So that we can link mothers and babies together |
Using all the information from this study and from other information sources we can complete the whole picture for mothers and babies and understand as much as possible about this new virus.
The completed questionnaire will be sent by the doctor to the BPSU-COVID-19 study team at the National Perinatal Epidemiology Unit at the University of Oxford where the information will be stored electronically and analysed.
More information about the data we will collect is available on the privacy notice page.
How we will the information we collect be used?
We will analyse the information we collect and produce weekly reports which will be used to support the governments COVID-19 control measures as well as the prevention advice provided to pregnant women and parents of new babies. We will also write up the results in a paper which will be published in a medical journal so that doctors in other countries looking after mothers and babies will also benefit from the findings. We will make sure that when we write our reports and the paper that the information is presented so that individual mothers and babies will not be identifiable.
Collecting information without consent
Because we need to include all eligible babies and we need to collect this information very quickly we will not be asking parents for their consent for their information or their baby's information to be included in the study. We have obtained special approvals to carry out this study without parents' consent. More information about the approvals process is available on the privacy notice page. There is also more information about the legal basis for carrying out the study in this way on the privacy notice page.
Is it possible for parents to opt out of this study?
We hope that parents will understand the benefits of this research and will wish to participate. If parents do not wish the information about their baby to be included in the study, whilst they cannot opt out of the notification of their baby to the BPSU, they can opt out of the data collection. Before deciding to opt out we ask parents to read the full details about the study which are given on the privacy notice page.
Parents who wish to opt out can do this by either letting their baby's doctor (who is looking after them in the neonatal or paediatric intensive care unit) know they want to opt out, or by getting in touch with the study team by email (bpsu-covid@ndph.ox.ac.uk) or telephone (01865 289733). If we have received the data collection form already, we will delete the information we have received and this information will not be included in the study.
You can also write to us at the address below to ask to opt out:
BPSU COVID-19 study
National Perinatal Epidemiology Unit
Nuffield Department of Population Health
Richard Doll Building
University of Oxford Old Road Campus
Old Road
Headington, Oxford OX3 7LF
How can I get more information about the research?
If you have questions about the research you can read more information on the privacy notice page. You can email the study team at: bpsu-covid@ndph.ox.ac.uk, or telephone us on: 01865 289733. Alternatively you can get in touch with Professor Jenny Kurinczuk (who is Co-lead for the study) preferably by email at present:
Or by mail or telephone:
Professor Jenny Kurinczuk
Director, National Perinatal Epidemiology Unit
Director, NIHR Policy Research Unit in Maternal and Neonatal Health and Care
Nuffield Department of Population Health
University of Oxford Old Road Campus
Headington, Oxford OX3 7LF
Tel: 01875 617909
