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Neonatal Complications of Coronavirus Disease (COVID-19)

NCT04386109 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2020-05-13

No results posted yet for this study

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.

Conditions

  • Neonatal COVID-19 Disease

Interventions

OTHER

No intervention - exposure is to COVID-19

No intervention - exposure is to COVID-19

Sponsors & Collaborators

  • Imperial College London

    collaborator OTHER

  • University of Leicester

    collaborator OTHER

  • University of Nottingham

    collaborator OTHER

  • University of Glasgow

    collaborator OTHER

  • University Hospital of Wales

    collaborator OTHER

  • Public Health England

    collaborator OTHER_GOV

  • St George's, University of London

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Professor J Kurinczuk, MBChB,MSc,MD · University of Oxford

  • Dr C Gale, MBBS,MSc,PhD · Imperial College London

Eligibility

Min Age
1 Day
Max Age
29 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2021-03-31
Completion
2021-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04386109 on ClinicalTrials.gov