Neonatal SARS-CoV-2 Anti-spike Protein Receptor-binding Domain Antibodies at Delivery

Active, not recruiting

• Conditions: COVID-19

• Registration Number: NCT05564884
• Lead Sponsor: Rabin Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-09-12
• Primary Completion: 2022-02-24
• Status Verified: 2022-09
• Study First Submitted: 2022-09-29
• Study First Submitted QC: 2022-09-29
• Last Update Submitted: 2022-09-29
• Study First Posted: 2022-10-04
• Last Update Posted: 2022-10-04
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 58

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

(a) preterm birth at <34 weeks gestation; (b) congenital or acquired immune deficiency, including recipient of biological agents during the prior year to enrolment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
neonatal anti-spike antibody levels	6 months	Primary outcomes were neonatal anti-spike antibody levels at delivery and infant microbiologically-confirmed COVID-19 infection at age \<6 months

Trial Locations

Locations (1)

Schneider Children's Medical Center; 🇮🇱 Petach Tikva, Israel