Neonatal Complications of Coronavirus Disease (COVID-19)

May 12, 2020 updated by: University of Oxford

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.

Study Overview

Status

Unknown

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

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Babies admitted for neonatal care in: a neonatal unit, a paediatric intensive care unit or an in-patient ward.

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
April 2020 to March 2021
Incidence of vertically transmitted COVID-19
Time Frame: April 2020 to March 2021
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 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
Presentation of neonates with COVID-19 positive mothers
Time Frame: April 2020 to March 2021
Questionnaire data
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
Clinical treatment of neonatal COVID-19
Time Frame: April 2020 to March 2021
Questionnaire data
April 2020 to March 2021
Neonatal secondary impacts of maternal COVID-19
Time Frame: April 2020 to March 2021
Questionnaire data
April 2020 to March 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Anticipated)

March 31, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 13, 2020

Study Record Updates

Last Update Posted (Actual)

May 13, 2020

Last Update Submitted That Met QC Criteria

May 12, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Share relevant data to international registries of neonatal COVID-19 which are being developed.

IPD Sharing Time Frame

Within 6 months of the study start

IPD Sharing Access Criteria

Funded registry with appropriate approvals to receive data

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

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Neonatal COVID-19 Disease

Clinical Trials on No intervention - exposure is to COVID-19

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