Impact of COVID-19 Infection During Pregnancy on Newborns and Young Children (ELIKYA COVID)
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| ClinicalTrials.gov Identifier: NCT04432779 |
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Recruitment Status :
Active, not recruiting
First Posted : June 16, 2020
Last Update Posted : September 16, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| Pregnancy Covid-19 | Other: no intervention |
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 |
| 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 |
|---|---|
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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 |
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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 |
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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 |
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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 |
- Outcome of pregnancy [ Time Frame: Up to the delivery ]Incidence of miscarriage, premature delivery, low birth weight, preeclampsia, chorioamnionitis
- 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
Biospecimen Retention: Samples Without DNA
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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 |
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
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
| Belgium | |
| CHU SAINT Pierre | |
| Brussels, Belgium, 1000 | |
| Principal Investigator: | Tessa Goetghebuer, MD PhD | Centre Hospitalier Universitaire Saint Pierre |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Covid-19 Pregnancy antibodies congenital SARS infection breast milk |
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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 |