To evaluate the prevalence of SARS-CoV2 antibodies in breast milk of lactating mothers recovering from a proven or suspected SARS-CoV2 infection.Secundary: to evaluate the effect of the corona-pandemic on pyschological en biological stress in…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
IgG and IgA against SARS-CoV2 will be determined in the collected blood samples.
Secretory IgA will be assessed in breast milk samples.
Cortisol in hair will be measured
Secondary outcome
All the data out of the questionnaire about general health, physical activity,
COVID-19 symptomens, diet, perceived stress.
Background summary
Coronavirus disease 2019 (COVID-19) first started in China in December 2019 and
the outbreak was declared a pandemic by the World Health Organization (WHO) on
11 March 2020. There are vulnerable populations suffering severely from
COVID-19 and some need to be hospitalized. Until now, there is no effective
treatment or vaccine available. In general, maternal milk antibodies may
provide additional protection to infants. Unpublished data from our recent
study showed the presence of SARS-CoV2 antibodies in breastmilk in previously
infected or suspected subjects, before and after pasteurization of the milk.
However, this was tested in a small group of women and to be able to implement
the antibody containing breastmilk into clinical practice we need to evaluate
the prevalence of SARS-CoV2 antibodies in breastmilk in a larger population. In
addition we want to study the amount of stress the pandemic has caused on this
specific population that underwent a life event during this pandemic and its
influence on the composition of milk. Moreover, we will evaluate the effect of
vaccination on antibodies.
Study objective
To evaluate the prevalence of SARS-CoV2 antibodies in breast milk of lactating
mothers recovering from a proven or suspected SARS-CoV2 infection.
Secundary: to evaluate the effect of the corona-pandemic on pyschological en
biological stress in lactating women and the effect on antibody levels in
breast milk.
To evaluate the effect of vaccination on the SARS-CoV-2 antibodies in breast
milk and to evaluate the evolution of the antibodies following the first and
second dose of the vaccine.
Study design
The study will be a prospective observational cohort study in which all
participants will undergo blood sampling for circulating antibody analyses
(specific IgG and IgA against SARS-CoV2) and breast milk sampling for antibody
analysis (IgA against SARS-CoV2). Also, for this study a small strand of hair
will be collected for cortisol analysis.
In addition, all participants will receive a questionnaire with questions
regarding their general health and characteristics, diet, perceived stress,
physical
activity, pregnancy and COVID-19 symptoms.
The vaccination follow-up study is a longitidinal study in which several blood
and milk samples will be collected to evaluate the effect of vaccination on the
antibodies.
Study burden and risks
We expect a low burden and low risk for the participating women. Participants
can choose if they want to come to the Amsterdam UMC for the collection of body
materials or that they would rather want the investigators to plan a home visit
so that they don't have to travel. The only risks are pain and bleeding due to
the vena puncture.
For the follow-up study, the risk is low.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Lactating women
- For the follow-up study: participants who recieve a COVID-19 vaccination
Exclusion criteria
• No written informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74752.029.20 |