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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

Tracking Information
First Submitted Date June 15, 2020
First Posted Date June 16, 2020
Last Update Posted Date September 16, 2021
Actual Study Start Date May 25, 2020
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 15, 2020)
Outcome of pregnancy [ Time Frame: Up to the delivery ]
Incidence of miscarriage, premature delivery, low birth weight, preeclampsia, chorioamnionitis
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 15, 2020)
  • Prevalence of positive serology to SARS-CoV-2 at delivery [ Time Frame: At the delivery ]
    Measure of antibodies in maternal serum at 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
  • 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
  • Presence of maternal antibodies to SARS-CoV-2 in breast milk in breastfeeding mothers [ Time Frame: 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
  • Clinical evolution of the children [ Time Frame: Up to 3 years ]
    Occurence of infectious disease, neurological development, growth
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of COVID-19 Infection During Pregnancy on Newborns and Young Children
Official Title Impact of SARS-CoV-2 Infection During Pregnancy on Newborns and Young Children
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Maternal specimens (placental tissue, serum, breast milk), Newborn specimens (umbilical cord blood)and infant specimens (serum)
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
Condition
  • Pregnancy
  • Covid-19
Intervention Other: no intervention
no intervention
Study Groups/Cohorts
  • 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.

    Intervention: Other: 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.

    Intervention: Other: 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.

    Intervention: Other: 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.

    Intervention: Other: no intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: June 15, 2020)
3000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT04432779
Other Study ID Numbers Elikya Covid
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire Saint Pierre
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
PRS Account Centre Hospitalier Universitaire Saint Pierre
Verification Date September 2021