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

Covid-19 Clinical Trial

— ELIKYA COVID  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04432779
• Other study ID #: Elikya Covid
• Status: Active, not recruiting
• Start date: May 25, 2020
• Est. completion date: June 2024

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Covid-19
• Infections
• Pregnancy

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
Belgium	CHU SAINT Pierre	Brussels

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre	Institute for Medical Immunology (IMI), Laboratoire Hospitalier Universitaire de Bruxelles (LHUB)

Country where clinical trial is conducted

Belgium, 

References & Publications (9)

Alzamora MC, Paredes T, Caceres D, Webb CM, Valdez LM, La Rosa M. Severe COVID-19 during Pregnancy and Possible Vertical Transmission. Am J Perinatol. 2020 Jun;37(8):861-865. doi: 10.1055/s-0040-1710050. Epub 2020 Apr 18. — View Citation

Dashraath P, Wong JLJ, Lim MXK, Lim LM, Li S, Biswas A, Choolani M, Mattar C, Su LL. Coronavirus disease 2019 (COVID-19) pandemic and pregnancy. Am J Obstet Gynecol. 2020 Jun;222(6):521-531. doi: 10.1016/j.ajog.2020.03.021. Epub 2020 Mar 23. Review. — View Citation

Dauby N, Goetghebuer T, Kollmann TR, Levy J, Marchant A. Uninfected but not unaffected: chronic maternal infections during pregnancy, fetal immunity, and susceptibility to postnatal infections. Lancet Infect Dis. 2012 Apr;12(4):330-40. doi: 10.1016/S1473-3099(11)70341-3. Epub 2012 Feb 24. Review. — View Citation

Di Mascio D, Khalil A, Saccone G, Rizzo G, Buca D, Liberati M, Vecchiet J, Nappi L, Scambia G, Berghella V, D'Antonio F. Outcome of coronavirus spectrum infections (SARS, MERS, COVID-19) during pregnancy: a systematic review and meta-analysis. Am J Obstet Gynecol MFM. 2020 May;2(2):100107. doi: 10.1016/j.ajogmf.2020.100107. Epub 2020 Mar 25. — View Citation

Goetghebuer T, Smolen KK, Adler C, Das J, McBride T, Smits G, Lecomte S, Haelterman E, Barlow P, Piedra PA, van der Klis F, Kollmann TR, Lauffenburger DA, Alter G, Levy J, Marchant A. Initiation of Antiretroviral Therapy Before Pregnancy Reduces the Risk of Infection-related Hospitalization in Human Immunodeficiency Virus-exposed Uninfected Infants Born in a High-income Country. Clin Infect Dis. 2019 Mar 19;68(7):1193-1203. doi: 10.1093/cid/ciy673. — View Citation

McHenry MS, McAteer CI, Oyungu E, McDonald BC, Bosma CB, Mpofu PB, Deathe AR, Vreeman RC. Neurodevelopment in Young Children Born to HIV-Infected Mothers: A Meta-analysis. Pediatrics. 2018 Feb;141(2). pii: e20172888. doi: 10.1542/peds.2017-2888. — View Citation

Muldoon KM, Fowler KB, Pesch MH, Schleiss MR. SARS-CoV-2: Is it the newest spark in the TORCH? J Clin Virol. 2020 Jun;127:104372. doi: 10.1016/j.jcv.2020.104372. Epub 2020 Apr 14. Review. — View Citation

Sutton D, Fuchs K, D'Alton M, Goffman D. Universal Screening for SARS-CoV-2 in Women Admitted for Delivery. N Engl J Med. 2020 May 28;382(22):2163-2164. doi: 10.1056/NEJMc2009316. Epub 2020 Apr 13. — View Citation

Vohr BR, Poggi Davis E, Wanke CA, Krebs NF. Neurodevelopment: The Impact of Nutrition and Inflammation During Preconception and Pregnancy in Low-Resource Settings. Pediatrics. 2017 Apr;139(Suppl 1):S38-S49. doi: 10.1542/peds.2016-2828F. Review. — View Citation

Outcome

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