Covid19GIFTNCT04802278
Gestational Immunity for Transfer
An observational study of Covid19 and Breastfeeding, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This is a study prospective cohort study at an urban academic centre, with two parts: 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Covid19, Breastfeeding, Vaccine Exposure Via Breast Milk
- What is being tested?
- COVID-19 vaccine
- Type of treatment
- Vaccines
- How many people
- 120 participants
- Where
- 1 siteSingapore
- Study dates
- 1 May 2020to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Part 1 of study - infants Part 2 of study - lactating women
Who may be able to join
- Lives in Singapore
Who cannot join
- Prematurity Congenital abnormalities Primary immunodeficiencies Autoimmune disorders
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore
Jia Ming Low, MBBS, MCI, jia_ming_low@nuhs.edu.sg
About this study
This is a study prospective cohort study at an urban academic centre, with two parts:
- 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
- Safety and protective properties of breast milk after lactating women are vaccinated against COVID-19
Read the detailed description
This proposal aims to provide a multi-faceted approach to study how immunity may be transferred - both transplacentally and through breastfeeding, from mother to child, in the context of COVID-19.
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
- Covid19, Breastfeeding, Vaccine Exposure Via Breast Milk
- Being tested
- COVID-19 vaccine
- Medical subject headings
- COVID-19, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccineBiological
Any COVID-19 vaccine
| Study group | Role | What they receive |
|---|---|---|
| Babies born to mothers convalescent from antenatal COVID-19 | Not described | |
| Babies born to healthy mothers | Not described | |
| Vaccinated mothers | Lactating mothers who received COVID-19 vaccination Receives: Biological: COVID-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplacentally transferred antibodies
Binding and neutralising immunoglobulin G specific to SARS-CoV-2 spike and receptor-binding domain
Measured: From birth to 12 months of age
Antibodies transferred through breast milk (convalescent mothers)
Binding and neutralising immunoglobulin A specific to SARS-CoV-2 spike and receptor-binding domain
Measured: From birth to 6 months of age
Antibodies transferred through breast milk (vaccinated mothers)
Binding and neutralising immunoglobulin A specific to SARS-CoV-2 spike and receptor-binding domain
Measured: From just before vaccination, to 6 weeks after vaccination
Secondary outcomes (1)
General health
Growth and development of infants
Measured: From birth to 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 May 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore, Agency for Science, Technology and Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802278
- Sponsor's protocol ID
- 2021/00095
- Acronym
- GIFT
- Status last verified
- Mar 2021
- First submitted
- 15 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36186648Low 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.
PubMed 34713745
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gestational Immunity for Transfer
- ClinicalTrials.gov ID
- NCT04802278
- Acronym / sponsor ID
- GIFT / 2021/00095
- Conditions
- Covid19, Breastfeeding, Vaccine Exposure Via Breast Milk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore, Agency for Science, Technology and Research
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study prospective cohort study at an urban academic centre, with two parts:
- 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
- Safety and protective properties of breast milk after lactating women are vaccinated against COVID-19
Detailed description
This proposal aims to provide a multi-faceted approach to study how immunity may be transferred - both transplacentally and through breastfeeding, from mother to child, in the context of COVID-19.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Babies born to mothers convalescent from antenatal COVID-19 | – | – |
| Babies born to healthy mothers | – | – |
| Vaccinated mothers | – | Biological: COVID-19 vaccineLactating mothers who received COVID-19 vaccination |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Part 1 of study - infants Part 2 of study - lactating women
Key inclusion criteria (1 listed)
- Lives in Singapore
Key exclusion criteria (1 listed)
- Prematurity Congenital abnormalities Primary immunodeficiencies Autoimmune disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 vaccineAny COVID-19 vaccine | Biological | Vaccinated mothers |
Primary outcome
Transplacentally transferred antibodies
Time frame: From birth to 12 months of age
Binding and neutralising immunoglobulin G specific to SARS-CoV-2 spike and receptor-binding domain
Antibodies transferred through breast milk (convalescent mothers)
Time frame: From birth to 6 months of age
Binding and neutralising immunoglobulin A specific to SARS-CoV-2 spike and receptor-binding domain
Antibodies transferred through breast milk (vaccinated mothers)
Time frame: From just before vaccination, to 6 weeks after vaccination
Binding and neutralising immunoglobulin A specific to SARS-CoV-2 spike and receptor-binding domain
1 secondary outcome
General health
Time frame: From birth to 12 months of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Derived from this study: PubMed 36186648Gu 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.
- Derived from this study: PubMed 34713745Low 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Breastfeeding, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia Ming Low, MBBS, MCI (+65 6779 5555, jia_ming_low@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplacentally transferred antibodies (time frame: From birth to 12 months of age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04802278, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.