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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-12

Study Completion Date

2022-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Multisite Observational Maternal and Infant Study for COVID-19

NCT05031468

COVID-19

COMPLETED

Priming of the NEonatal Immune System by Transfer of Maternal Immunity

NCT05429047

COVID-19 Maternal Vaccine Exposure Respiratory Infections in Children

UNKNOWN

COVID-10 in the Pediatric Population: SARS-CoV-2 Seropositivity

NCT04690114

SARS-CoV-2 Infection

UNKNOWN

Safety Study of an Intravenous Staphylococcus Aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates

NCT00066989

Staphylococcal Infections

COMPLETED PHASE2

SARS-CoV2 Antibodies in Pediatric Patients (COVID-19)

NCT04581148

SARS-Cov2

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Unvaccinated, Prior natural COVID-19 infection

no intervantion

Intervention Type OTHER

no intervention

Vaccinated, No prior natural COVID-19 infection

no intervantion

Intervention Type OTHER

no intervention

Vaccinated, Prior natural COVID-19 infection

no intervantion

Intervention Type OTHER

no intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

no intervantion

no intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No