Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2020-05-01
2021-12-01
Brief Summary
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1. Health outcomes, and maternally transferred antibodies, in babies born to mothers who had antenatal COVID-19 and convalesced before delivery, followed up until 12 months of age
2. Safety and protective properties of breast milk after lactating women are vaccinated against COVID-19
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Detailed Description
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We first recruit all babies delivered to mothers convalescent from antenatal COVID-19, to 1) follow up their growth and development, and 2) study the protective effects of antibodies transferred from mother to child transplacentally during pregnancy, as well as postnatally through breastfeeding. We compare these to a cohort of healthy controls whose mothers did not have COVID-19 during pregnancy.
Next, we compare the protective effects of antibodies transferred during breastfeeding from mother to child after lactating mothers are vaccinated against COVID-19, to that of natural infection. We also study the safety of breastfeeding after vaccination by looking for vaccine components in the breast milk.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Babies born to mothers convalescent from antenatal COVID-19
No interventions assigned to this group
Babies born to healthy mothers
No interventions assigned to this group
Vaccinated mothers
Lactating mothers who received COVID-19 vaccination
COVID-19 vaccine
Any COVID-19 vaccine
Interventions
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COVID-19 vaccine
Any COVID-19 vaccine
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
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National University of Singapore
OTHER
Agency for Science, Technology and Research
OTHER
National University Hospital, Singapore
OTHER
Responsible Party
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Locations
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National University Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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References
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Gu Y, Low JM, Tan JSY, Ng MSF, Ng LFP, Shunmuganathan B, Gupta R, MacAry PA, Amin Z, Lee LY, Lian D, Shek LP, Zhong Y, Wang LW. Immune and pathophysiologic profiling of antenatal coronavirus disease 2019 in the GIFT cohort: A Singaporean case-control study. Front Pediatr. 2022 Sep 15;10:949756. doi: 10.3389/fped.2022.949756. eCollection 2022.
Low JM, Lee LY, Ng YPM, Zhong Y, Amin Z. Breastfeeding Mother and Child Clinical Outcomes After COVID-19 Vaccination. J Hum Lact. 2022 Feb;38(1):37-42. doi: 10.1177/08903344211056522. Epub 2021 Oct 29.
Other Identifiers
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2021/00095
Identifier Type: -
Identifier Source: org_study_id
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