Neonatal Complications of Coronavirus Disease (COVID-19)

Neonatal COVID-19 Disease Clinical Trial

Official title:

Neonatal Complications of Coronavirus Disease (COVID-19)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04386109
• Other study ID #: 14905
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: April 2020
• Source: University of Oxford
• Contact: Professor J Kurinczuk, MBChB,MSc,MD
• Phone: int+ 44 (0)7775516686
• Email: jenny.kurinczuk[@]npeu.ox.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 29 Days

Eligibility

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:

Related Conditions & MeSH terms

• Coronavirus Infections
• Neonatal COVID-19 Disease

Intervention

Other:
• No intervention - exposure is to COVID-19
No intervention - exposure is to COVID-19

Locations

Country	Name	City	State
United Kingdom	Imperial College	London

Sponsors (8)

Lead Sponsor	Collaborator
University of Oxford	Imperial College London, Public Health England, St George's, University of London, University Hospital of Wales, University of Glasgow, University of Leicester, University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of neonatal COVID-19	Number of neonatal participants with COVID-19 divided by the total number of live births in the population	April 2020 to March 2021
Primary	Incidence of vertically transmitted COVID-19	Number of neonatal participants with COVID-19 following vertically transmission of the Coronavirus divided by the total number of live births in the population	April 2020 to March 2021
Secondary	Presentation and natural history of neonatal COVID-19	Questionnaire data	April 2020 to March 2021
Secondary	Presentation of neonates with COVID-19 positive mothers	Questionnaire data	April 2020 to March 2021
Secondary	Outcomes for neonates with COVID-19	Proportion of neonate participants who died and the proportion who were discharged home alive.	April 2020 to March 2021
Secondary	Clinical treatment of neonatal COVID-19	Questionnaire data	April 2020 to March 2021
Secondary	Neonatal secondary impacts of maternal COVID-19	Questionnaire data	April 2020 to March 2021