There is an evidence gap in relation to the incidence, impact and severity of COVID-19 in newborn babies. International data are very limited, we have no robust estimates of incidence and no UK-based data with which to inform policy, clinical care, service delivery or advice to pregnant women. The research aims are to investigate the three mains ways in which COVID-19 might affect newborns and babies that need neonatal care: 1. Newborn babies might catch COVID-19 before, during or soon after birth and this may lead to problems with breathing or feeding that need support in hospital. 2. COVID-19 could affect babies that are already on neonatal units with other medical conditions (like being very premature) that place them at greater risk of severe COVID-19. 3. COVID-19 might affect that way that pregnant women are looked after in pregnancy, labour or bith which could lead to problems for some babies, even if they do not themselves become infected with COVID-19.
The investigators have established a national (UK-wide) active surveillance study using the
standard British Paediatric Surveillance Unit (BPSU) approach.
Since the 1st April 2020 case notifications are being collected using the BPSU 'orange eCard'
approach. Eligible babies are: neonatal COVID-19 in babies (<29 days old) in neonatal units,
paediatric intensive care units and other in-patient locations and where neonates are born to
COVID-19 mothers and require neonatal care. Notification cards are being sent weekly rather
than the usual monthly pattern, this is so we are able to monitor case returns in
'real-time'. When paediatricians notify a case they are sent a data collection sheet which is
returned complete to the BPSU-COVID-19 team at the NPEU.
The primary data collected in the study will also be cross-linking with data from: a parallel
NIHR funded study of COVID-19 mothers being carried out using the UK Obstetric Surveillance
System (UKOSS); MBRRACE-UK, the national surveillance of perinatal deaths; the Paediatric
Intensive Care Audit Network (PICANet); and PHE England, PHS Scotland, PHS Wales and the HSC
Public Health Agency Northern Ireland. This is to ensure complete case ascertainment. A later
linkage will be carried out with the National Neonatal Research Database (NNRD) in order to
collect more detailed clinical information.
As data are weekly reports of the findings will be generated to inform the development of
policy and practice. The findings will be sent together with the UKOSS findings to: the
decision makers responsible for the COVID-19 control policy at NHSE, DHSC, the Scottish,
Welsh and NI governments, as well as the Royal Colleges of Paediatrics and Child Health and
Obstetricians and Gynaecologists (RCPCH & RCOG respectively), and the British Association of
Perinatal Medicine (BAPM). This will ensure that policy, advice to pregnant women and parents
and guidance for practice benefits from the most up to date information.
Follow-up at 3 months post-notification will be carried out in order to collect the final
outcomes for each baby as the first data collection will be completed when a substantial
proportion of babies will still be in-patients.
Data will also be shared (subject to appropriate approvals and data sharing agreements) with
the COVID-19 registries that are being developed in the UK and across Europe.
Other: No intervention - exposure is to COVID-19
No intervention - exposure is to COVID-19
Inclusion Criteria:
- Any baby:
1. That has a diagnosis of COVID-19 made on a sample taken before 29 days of age and
receives inpatient care for COVID-19 (this includes postnatal ward, neonatal
unit, paediatric inpatient wards, PICU) OR
2. Where the mother had confirmed COVID-19 at the time of birth or suspected
COVID-19 at the time of birth that has subsequently been confirmed, and the baby
was admitted for neonatal care
Exclusion Criteria:
Imperial College
London, United Kingdom
Investigator: Dr C Gale, MBBS,MSc,PhD
Contact: int + 44 (0) 202 3315 3519
christopher.gale@imperial.ac.uk
Professor J Kurinczuk, MBChB,MSc,MD
int+ 44 (0)7775516686
jenny.kurinczuk@npeu.ox.ac.uk
Dr C Gale, MBBS,MSc,PhD
int + 44 (0)20 3315 3519
christoper.gale@imperial.ac.uk