Neonatal Complications of Coronavirus Disease (COVID-19) Study [COVID-19] [UPH]
Research type
Research Study
Full title
Neonatal Complications of Coronavirus Disease (COVID-19) Study
IRAS ID
282127
Contact name
Jennifer J Kurinczuk
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
ISRCTN60033461
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Research Summary
This study will collect information about newborn babies admitted to hospital who have Coronavirus (COVID-19) or who are born to mothers who have COVID-19 and require hospital care. The information we collect will help us to understand: how babies get COVID-19; what happens to babies when their mother has COVID-19; what treatments are effective in helping babies with COVID-19 to get better; and what happens to babies when they have been treated. We are carrying out the study through a system called the British Paediatric Surveillance Unit (BPSU) www.rcpch.ac.uk/work-we-do/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 COVID-19 or whose mother has COVID-19. If they have, they will be sent a questionnaire to collect information about the baby and their mother. This identifiable information will be shared with us under special temporary provisions introduced in England & Wales by the Secretary of State for Health and Social Care to allow the processing of confidential patient information without consent for COVID-19 public health, surveillance and research purposes during the current pandemic. [Study relying on COPI notice].
Summary of Research
This was a UK national study of two sets of babies affected by Coronavirus: (i) those babies who were infected with the Coronavirus (SARS-CoV-2) and needed hospital care; (ii) and those babies whose mothers had COVID-19 where her baby was admitted for care on a neonatal unit after birth. We started the study on 1st April 2020 collecting data about babies admitted from 1st March 2020 using the British Paediatric Surveillance Unit (British Paediatric Surveillance Unit (rcpch.ac.uk)) study system.
We produced weekly reports for the first year of the pandemic and then monthly reports of the finding. We sent these report to the organisations responsible for the national response to the pandemic and for issuing COVID-19 guidance to doctors, midwives, pregnant women and parents. The organisations included the Department of Health (England), devolved governments, the Royal College of Obstetricians and Gynaecologists, the Royal College of Midwives, the Royal College of Paediatrics and Child Health and the British Association of Perinatal Medicine.
The first set of results from the study were for babies in the UK with confirmed SARS-CoV-2 infection in the first 28 days after they were born who received hospital care between 1st March and 30th April 2020; the start of the first wave of the Coronavirus pandemic. We found that baby infection with SARS-CoV-2 around the time of birth was uncommon in babies admitted to hospital. When babies were infected the infection was generally mild or without symptoms. When mothers had COVID-19 around the time of birth their babies were rarely infected, this supported the national guidance to avoid separation of mothers and babies at birth. There was a high proportion of babies from Black, Asian and minority ethnic groups; this was similar to what was happening in the adult population at this stage of the pandemic. The full results are available here: https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC7818530%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ca5eb05c3990747756c9308db3687b84b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638163728756182045%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=IMJQ8jWIHeibgYGlEhyZ0%2FppDMxc0dWVMlaR3MXqa9c%3D&reserved=0
The second set of findings were for babies admitted to a neonatal unit (NNU) following birth to a mother with confirmed SARS-CoV-2 infection within 7 days of birth for the period 1st March 2020 to 31st August 2020. We included information in this study from another study running at the same time of pregnant women admitted to hospital with COVID-19 and from the national database of all babies admitted to a neonatal unit (NNU). We found that NNUS admissions of babies born to mothers with SARS-CoV-2 infection accounted for a very small proportion of all admissions to NNUs in the first 6 months of the pandemic. A high proportion of babies needing neonatal admission who were born to mothers with confirmed SARS-CoV-2 infection were born premature and were infected with SARS-CoV-2. Poor neonatal outcomes were more common in babies whose SARS-CoV-2-positive mothers themselves required admission for intensive care compared with those whose SARS-CoV-2-positive mothers who did not. The full results are available here: https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC10000338%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ca5eb05c3990747756c9308db3687b84b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638163728756182045%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=EJFkg%2BTQEirtUeOBHNpon7i7o4fkXAGt7kdLwefsFr4%3D&reserved=0
The third set and final set of findings relate to babies with confirmed SARS-CoV-2 infection in the first 28 days after birth who received hospital care through the four main waves of the pandemic from 1st March 2020 to 1st April 2022. These results have not yet been published, but as with the first two sets of results, the findings are generally reassuring.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
20/NE/0107
Date of REC Opinion
30 Mar 2020
REC opinion
Favourable Opinion