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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04432779
Recruitment Status : Active, not recruiting
First Posted : June 16, 2020
Last Update Posted : September 16, 2021
Sponsor:
Collaborators:
Institute for Medical Immunology (IMI)
Laboratoire Hospitalier Universitaire de Bruxelles (LHUB)
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Saint Pierre

Brief Summary:
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.

Condition or disease Intervention/treatment
Pregnancy Covid-19 Other: no intervention

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.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of SARS-CoV-2 Infection During Pregnancy on Newborns and Young Children
Actual Study Start Date : May 25, 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

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




Primary Outcome Measures :
  1. Outcome of pregnancy [ Time Frame: Up to the delivery ]
    Incidence of miscarriage, premature delivery, low birth weight, preeclampsia, chorioamnionitis


Secondary Outcome Measures :
  1. Prevalence of positive serology to SARS-CoV-2 at delivery [ Time Frame: At the delivery ]
    Measure of antibodies in maternal serum at delivery

  2. Transplacental transfer of antibodies to SARS-CoV-2 [ Time Frame: At the delivery ]
    Measure the ratio of cord blood antibodies on maternal antibodies titers

  3. 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

  4. Presence of maternal antibodies to SARS-CoV-2 in breast milk in breastfeeding mothers [ Time Frame: At 1 month post delivery ]
  5. 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

  6. Clinical evolution of the children [ Time Frame: Up to 3 years ]
    Occurence of infectious disease, neurological development, growth


Biospecimen Retention:   Samples Without DNA
Maternal specimens (placental tissue, serum, breast milk), Newborn specimens (umbilical cord blood)and infant specimens (serum)


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04432779


Locations
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Belgium
CHU SAINT Pierre
Brussels, Belgium, 1000
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Institute for Medical Immunology (IMI)
Laboratoire Hospitalier Universitaire de Bruxelles (LHUB)
Investigators
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Principal Investigator: Tessa Goetghebuer, MD PhD Centre Hospitalier Universitaire Saint Pierre
Publications:

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Responsible Party: Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT04432779    
Other Study ID Numbers: Elikya Covid
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire Saint Pierre:
Covid-19
Pregnancy
antibodies
congenital SARS infection
breast milk
Additional relevant MeSH terms:
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Infections
COVID-19
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases