Neonatal Complications of Coronavirus Disease (COVID-19)

NCT04386109 | Unknown

• 1 other identifier: 14905
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Presentation and natural history of neonatal COVID-19

  April 2020 to March 2021

• Presentation of neonates with COVID-19 positive mothers

  April 2020 to March 2021

• Outcomes for neonates with COVID-19

  April 2020 to March 2021

• Clinical treatment of neonatal COVID-19

  April 2020 to March 2021

• Neonatal secondary impacts of maternal COVID-19

  April 2020 to March 2021

Study Arms (2)

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.

Other: 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

Other: No intervention - exposure is to COVID-19

Interventions

No intervention - exposure is to COVID-19 OTHER

No intervention - exposure is to COVID-19

Neonates COVID-19 positive; Neonates born to COVID-19 positive mothers

Eligibility Criteria

• Age: 1 Day - 29 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Imperial College London: collaborator
• University of Leicester: collaborator
• University of Nottingham: collaborator
• University of Glasgow: collaborator
• University Hospital of Wales: collaborator
• Public Health England: collaborator
• St George's, University of London: collaborator

Study Sites (1)

Imperial College

London, United Kingdom

RECRUITING

Study Officials

• Professor J Kurinczuk, MBChB,MSc,MD

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Dr C Gale, MBBS,MSc,PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Professor J Kurinczuk, MBChB,MSc,MD

CONTACT

int+ 44 (0)7775516686; jenny.kurinczuk@npeu.ox.ac.uk

Dr C Gale, MBBS,MSc,PhD

CONTACT

int + 44 (0)20 3315 3519; christoper.gale@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: May 13, 2020
• Study Start: April 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: September 30, 2021
• Last Updated: May 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Within 6 months of the study start
• Access Criteria: Funded registry with appropriate approvals to receive data

Locations

GB (1)