Condition category
Infections and Infestations
Date applied
30/07/2020
Date assigned
31/07/2020
Last edited
31/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Backgroud and study aims
Coronavirus disease (COVID-19) is an international public health crisis and is rapidly spreading around the world. So far it looks like most newborn babies and infants are not severely affected, but this is based on information about very small numbers of babies so there might be important effects of COVID-19 in babies that we don’t yet know about.

There are three main ways that COVID-19 might affect newborns and babies that need hosptial care when they are born or soon afterwards:
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 make them more at risk of severe infection.
3. COVID-19 might affect that way that pregnant women are looked after in pregnancy or labour which could lead to problems for some babies, even if they do not catch COVID-19

We plan to look at how COVID-19 is affecting newborns and babies who require hospital care in the United Kingdom (UK) through the British Paediatric Surveillance Unit (BPSU) notification system. To do this we will ask all paediatricians (doctors who look after babies and children) across the UK to report any baby they look after that is affected by COVID-19 as described above.

We will then ask the paediatricians looking after babies affected by COVID-19 some simple questions about how the baby is affected, what treatment they need, and what happens after the infection. We will use information that is routinely collected by doctors and nurses on neonatal units and paediatric intensive care units to better understand what medical treatments babies with COVID-19 receive. We will also link up with a similar surveillance study looking at COVID-19 in pregnant women (called UKOSS) and work with Public Health England (PHE) and similar organisations in Wales, Scotland and Northern Ireland to get a complete picture of the neonatal complications of COVID-19.

Who can participate?
Babies diagnosed with COVID-19 (SARS-CoV-2 infection) or born to mothers with COVID-19 (SARS-CoV-2 infection).

What does the study involve?
We will only collect information about the affected babies and this study will not affect the care that the babies receive.
The collection of information is from medical records only and does not require active participation by parents.

What are the possible benefits and risks of participating?
This is an 'observational' study which involves the collection of information from medical records and will not affect the care that babies receive and it thesefore does not involve any risks or benefits for the babies whose information is included.

Where is the study run from?
The study is being run by a collaboration of researchers from across the UK and is being organised from the National Perinatal Epidemiology Unit (NPEU) in the Nuffield Department of Population Health at the University of Oxford.

When is the study starting and how long is it expected to run for?
The study will collect information about eligible babies from 1st March 2020 to 31st March 2021. To ensure that we collect all the information require the study will continue until 30th September 2021.

Who is funding the study?
The study is funded by a grant provided by the NIHR Policy Research Programme through the NIHR Policy Research Unit in Maternal and Neonatal Health and Care which is based at the NPEU, University of Oxford and with collaborators at the Universities of Leicester, Birmingham, Cardiff, and Manchester, Imperial College London and University College London (PR-PRU-1217-21202).

Who is the main contact?
Dr Chris Gale, christopher.gale@imperial.ac.uk
Prof. Jenny Kurinczuk, jenny.kurinczuk@npeu.ox.ac.uk

Trial website

https://www.npeu.ox.ac.uk/pru-mnhc/research-themes/theme-4/covid-19

Contact information

Type

Scientific

Primary contact

Dr Christopher Gale

ORCID ID

http://orcid.org/0000-0003-0707-876X

Contact details

Neonatal Medicine
School of Public Health
Faculty of Medicine
Chelsea and Westminster Hospital campus
4th floor
lift bank D
369 Fulham Road
London
SW10 9NH
United Kingdom
+ 44 (0)203 3153519
christopher.gale@imperial.ac.uk

Type

Scientific

Additional contact

Prof Jenny Kurinczuk

ORCID ID

http://orcid.org/0000-0001-9554-6337

Contact details

National Perinatal Epidemiology Unit
Nuffield Department of Population Health
University of Oxford
University of Oxford Old Road Campus
Headington
Oxford
OX3 7LF
United Kingdom
+ 44 (0)77 7551 6686
jenny.kurinczuk@npeu.ox.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 282127

Study information

Scientific title

Neonatal complications of coronavirus disease (COVID-19) study

Acronym

Study hypothesis

Coronavirus disease (COVID-19) is an international public health crisis and has rapidly spread around the world. Evidence to date suggests that most newborn babies and infants are not severely affected, but this is based on small numbers of cases so there might be important effects of COVID-19 in babies that we don’t yet know about.

This observational study is designed to investigate the incidence, presentation, mode of transmission, severity, management and outcomes for hospitalised neonates diagnosed with SARS-CoV-2 before they are 29 days old; and the secondary impacts on babies born to mothers diagnosed with COVID-19 where the baby is admitted for hospital care.

Ethics approval

Approved 29/03/2020, North East - Newcastle & North Tyneside 2 Research Ethics Committee (NHS BT Blood Donor Centre, Holland Drive, Newcastle upon Tyne, Tyne and Wear NE2 4NQ, UK; +44 (0)207 972 2503; newcastlenorthtyneside2.rec@hra.nhs.uk), ref 20/NE/0107

Study design

Observational national prospective cohort study

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

COVID-19 (SARS-CoV-2 infection)

Intervention

Observational study: using the British Paediatric Surveillance Unit system we will collect information about presentation, mode of transmission, severity, management and outcomes for hospitalised neonates diagnosed with SARS-CoV-2 and the same information for babies born to mothers with COVID-19 disease from 1st March 2020 until 31st March 2021.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Incidence of neonatal COVID-19 and mode of transmission measured using patient records from the British Paediatric Surveillance Unit system from 1st March 2020 until 31st March 2021

Secondary outcome measures

Measured using patient records from the British Paediatric Surveillance Unit system from 1st March 2020 until 31st March 2021:
1. Presentation natural history and clinical presentation of neonatal hospitalised SARS-CoV-2
2. Presentation of neonates hospitalised whose mothers have COVID-19
3. Management, clinical treatment and outcomes of hospitalised neonates with SARS-CoV-2
4. Management, clinical treatment and outcomes of hospitalised neonates with SARS-CoV-2
5. Management, clinical treatment and outcomes of hospitalised neonates with SARS-CoV-2
6. Management, clinical treatment and outcomes of hospitalised neonates born to mothers with COVID-1

Overall trial start date

01/03/2020

Overall trial end date

30/09/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Two groups of babies are eligible for inclusion:
1. Babies who have a diagnosis of SARS-CoV-2 infection made on a sample taken in the first 28 days and received inpatient care on a postnatal ward, neonatal unit, paediatric inpatient ward or paediatric intensive care unit
2. Babies born to mothers with COVID-19 where the baby requires hospital care within the first 28 days after birth

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

As a national observational study we will include all eligible babies during the study period. The total number will not be known until we have finished recruiting.

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/03/2020

Recruitment end date

31/03/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
National Perinatal Epidemiology Unit Nuffield Department of Population Health Old Road Campus Headington
Oxford
OX3 7LF
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

The University of Oxford
Clinical Trials and Research Governance Joint Research Office
1st floor
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
United Kingdom
+ 44 (0) 1865 616494
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

We plan two publications in the first instance:
1. Analysis of the babies who have SARS-CoV-2 infection who were diagnosed in March and April 2020.
2. Analyis of both cohorts of babies, those with SARS-CoV-2 infection and those born to mothers with COVID-19 once the study has completed data collection.

IPD sharing statement:
Individual data will be shared with a global register of babies affected by COVID-19 and a prospective individual patient meta-analysis being carried out as a WHO collaboration.

Intention to publish date

31/08/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

30/07/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).