Impact of COVID-19 Infection During Pregnancy on Newborns and Young Children (ELIKYA COVID)

October 7, 2022 updated by: Centre Hospitalier Universitaire Saint Pierre

Impact of SARS-CoV-2 Infection During Pregnancy on Newborns and Young Children

This study aim is to assess impact of COVID-19 infection during pregnancy on outcome of pregnancy, and on developement of the child in early life.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

All pregnant women will be tested for serology during each trimester of pregnancy and at delivery, together with a nasal swab. Children born to women with positive sawb or serology will be followed up for 3 years together with a control child born to negative mother.

In positive mothers, maternal antibodies at delivery will be characterized, placental transfer will be assessed. Persistence of antibodies in children at the age of 1 month and presence of antibodies in breast milk will be measured.

Occurence of premature birth, low birth weight, miscarriage, congenital malformations will be compared in positive and negative mothers. Follow up of children over the first 3 years of life will assess difference in susceptibility to infections and neurological developement in both groups.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

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

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • CHU Saint Pierre

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All women who deliver in the CHU St Pierre and children born to positive mothers and controls matched on gestational age and ethnicity

Description

Inclusion Criteria:

  • For pregnant women, all women who deliver in the CHU St Pierre, with oral consent.
  • For children follow up: children born to positive mothers and matched controls after written consent

Exclusion Criteria:

  • none

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
Women tested positive to SARS-CoV-2 during pregnancy

All women who had a positive nasal swab or a positive serology during pregnancy or at delivery are included.

Follow up end at 1 month post delivery.
Other: no intervention
no intervention
Women tested negative to SARS-CoV-2 during pregnancy

All women who had a positive nasal swab or a positive serology during pregnancy or at delivery are included.

No follow up after delivery.
Other: no intervention
no intervention
Newborns from women tested positive

Newborns born to mothers who had a positive nasal swab or a positive serology during pregnancy or at delivery and who consented the follow up study.

Follow up end at 3 years of age.
Other: no intervention
no intervention
Newborns from women tested negative

Newborns born to mothers who had no COVID-19 infection during pregnancy or at delivery and who consented the follow up study. These control children will be matched with children from the other group for gestational age and ethnicity.

Follow up end at 3 years of age.
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome of pregnancy
Time Frame: Up to the delivery
Incidence of miscarriage, premature delivery, low birth weight, preeclampsia, chorioamnionitis
Up to the delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of positive serology to SARS-CoV-2 at delivery
Time Frame: At the delivery
Measure of antibodies in maternal serum at delivery
At the delivery
Transplacental transfer of antibodies to SARS-CoV-2
Time Frame: At the delivery
Measure the ratio of cord blood antibodies on maternal antibodies titers
At the delivery
To characterize placental alterations related to SARS-CoV-2 infection
Time Frame: At the delivery
Placental histology will be performed in women tested positive for SARS-CoV-2 during pregnancy
At the delivery
Presence of maternal antibodies to SARS-CoV-2 in breast milk in breastfeeding mothers
Time Frame: At 1 month post delivery
At 1 month post delivery
To characterize the immunity transmitted to the newborn to cord blood and its persistence at the age of 1 month of life
Time Frame: Up to 1 month post delivery
Measure of antibodies in cord blood and at the age of 1 month
Up to 1 month post delivery
Clinical evolution of the children
Time Frame: Up to 3 years
Occurence of infectious disease, neurological development, growth
Up to 3 years

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Collaborators

Institute for Medical Immunology (IMI)
Laboratoire Hospitalier Universitaire de Bruxelles (LHUB)

Investigators

  • Principal Investigator: Tessa Goetghebuer, MD PhD, Centre Hospitalier Universitaire Saint Pierre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 25, 2020

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 15, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

October 10, 2022

Last Update Submitted That Met QC Criteria

October 7, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Elikya Covid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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