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The Association of Neonatal SARS-CoV-2 Anti-spike Protein Receptor-binding Domain Antibodies at Delivery With Infant COVID-19 Infection Under Age 6 Months: a Prospective Cohort Study
To assess the association between neonatal SARS-CoV-2 antibody level at delivery and infant COVID-19 infection under age 6 months, and to identify predictive factors for neonatal antibody level at delivery.
This prospective observational study was conducted at the Rabin Medical Center, Israel. Mothers were enrolled from September 2021 to mid-February 2022, prior to transfer to the delivery room, and followed at the Maternity and Infant Ward. The study was approved by the institutional ethics committee (RMC- 0275-21). Written informed consent was obtained from the participating mothers. Inclusion criteria included maternal recipient of at least one dose of the BNT162b2 mRNA COVID-19 vaccine or prior microbiologically-confirmed natural COVID-19 infection. Exclusion criteria included (a) preterm birth at \<34 weeks gestation; (b) congenital or acquired immune deficiency, including recipient of biological agents during the prior year to enrolment.
Age
All ages
Sex
FEMALE
Healthy Volunteers
No
Schneider Children's Medical Center
Petah Tikva, Israel
Start Date
September 12, 2021
Primary Completion Date
February 24, 2022
Completion Date
November 1, 2022
Last Updated
October 4, 2022
58
ESTIMATED participants
no intervantion
OTHER
Lead Sponsor
Rabin Medical Center
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06631287