- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04386109
Neonatal Complications of Coronavirus Disease (COVID-19)
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:
- 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.
- 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.
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Professor J Kurinczuk, MBChB,MSc,MD
- Phone Number: int+ 44 (0)7775516686
- Email: jenny.kurinczuk@npeu.ox.ac.uk
Study Contact Backup
- Name: Dr C Gale, MBBS,MSc,PhD
- Phone Number: int + 44 (0)20 3315 3519
- Email: christoper.gale@imperial.ac.uk
Study Locations
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-
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London, United Kingdom
- Recruiting
- Imperial College
-
Contact:
- Dr C Gale, MBBS,MSc,PhD
- Phone Number: int + 44 (0) 202 3315 3519
- Email: christopher.gale@imperial.ac.uk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Any baby:
- 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
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:
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Neonates COVID-19 positive
1. Neonatal COVID-19 in babies (<29 days old) in neonatal units, paediatric intensive care units and other in-patient locations.
|
No intervention - exposure is to COVID-19
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Neonates born to COVID-19 positive mothers
2. Neonates (<29 days old) born to COVID-19 positive mothers requiring neonatal care
|
No intervention - exposure is to COVID-19
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of neonatal COVID-19
Time Frame: April 2020 to March 2021
|
Number of neonatal participants with COVID-19 divided by the total number of live births in the population
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April 2020 to March 2021
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Incidence of vertically transmitted COVID-19
Time Frame: April 2020 to March 2021
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Number of neonatal participants with COVID-19 following vertically transmission of the Coronavirus divided by the total number of live births in the population
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April 2020 to March 2021
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presentation and natural history of neonatal COVID-19
Time Frame: April 2020 to March 2021
|
Questionnaire data
|
April 2020 to March 2021
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Presentation of neonates with COVID-19 positive mothers
Time Frame: April 2020 to March 2021
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Questionnaire data
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April 2020 to March 2021
|
Outcomes for neonates with COVID-19
Time Frame: April 2020 to March 2021
|
Proportion of neonate participants who died and the proportion who were discharged home alive.
|
April 2020 to March 2021
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Clinical treatment of neonatal COVID-19
Time Frame: April 2020 to March 2021
|
Questionnaire data
|
April 2020 to March 2021
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Neonatal secondary impacts of maternal COVID-19
Time Frame: April 2020 to March 2021
|
Questionnaire data
|
April 2020 to March 2021
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Professor J Kurinczuk, MBChB,MSc,MD, University of Oxford
- Principal Investigator: Dr C Gale, MBBS,MSc,PhD, Imperial College London
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14905
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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