An observational study in COVID-19, sponsored by Rabin Medical Center. Status unknown at 1 site in Israel. Open to female participants. Per ClinicalTrials.gov, last updated 2022-10-04.
Sponsored by Rabin Medical Center · Observational
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.
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's planned enrollment of 58 is below the median of 260 across 3,188 observational studies indexed under COVID-19.
Browse COVID-19 studies →Rabin Medical Center is the lead sponsor of 393 studies on the registry; 30 are open to participants now.
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Mothers prior to transfer to the delivery room and followed at the Maternity and Infant Ward
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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.
Unvaccinated, Prior natural COVID-19 infection
Other: no intervantion
Vaccinated, No prior natural COVID-19 infection
Other: no intervantion
Vaccinated, Prior natural COVID-19 infection
Other: no intervantion
no intervention
neonatal anti-spike antibody levels
Primary outcomes were neonatal anti-spike antibody levels at delivery and infant microbiologically-confirmed COVID-19 infection at age \<6 months
Time frame: 6 months
Plan to share: No — According to ethics committee approval.
No publications or documents are linked to this record.
Ran from Sep 2021 to primary completion in Feb 2022, 5 months.
Of 1,625 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's 5 months is below that.
Counting every sponsor, half of 1,750 studies reached it within 13 months; a quarter within 5 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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