To investigate the effect of early life or pre-conceptional transgenerational events on healthy ageing and chronic disease in (early) childhood. Eventually this may lead to determine parameters for (early) life health and its impact on health. We…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gezondheid in het algemeen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Collection of biomaterials in 1500 - maximally 2000 subjects in the LLNEXT
cohort to correlate serological, metabolomic, microbiomic, genomic,
transcriptomic, epigenetic, medical, social and environmental factors to early
life health.
Secondary outcome
nvt
Background summary
To study intrinsic and external factors for health development in early
childhood cohort studies including immune status and microbiome, longitudinal
data in prenatal and early life of both the pregnant women and the newborns are
needed. We aim to build a birth cohort within Lifelines and include at least
1500 pregnant LL participants. This will enable us using -omics techniques to
correlate genomic, epigenetic, serological, metabolomic, microbiomic, medical,
social and environmental factors to early life health.
Study objective
To investigate the effect of early life or pre-conceptional transgenerational
events on healthy ageing and chronic disease in (early) childhood.
Eventually this may lead to determine parameters for (early) life health and
its impact on health. We will first relate microbiome (using metagenomic
sequencing) to early life development and early life events.
Study design
This is a non-therapeutic observational study with an expected duration of 3
years.
Study burden and risks
The study involves venepuncture, collection of nasal, mouth and vaginal smears,
placenta, stool, breast milk, exhaled breath and urine samples longitudinally
in mother and child. We will assess lung function in the new-borns. Data on
medical, environmental and social data acquired from questionnaires. In total
we will collect 2x30 ml venous blood from the mother, 1x max 10 ml of cord
blood, 3x max 1 ml capillary blood and 1x max 1 ml venous blood from the child.
In total a maximum of 19 bio samples from the child and 24 from the mother will
be taken. A maximum of 21 questionnaires about the child*s health and 26 about
the mothers/caregivers life style will be filled out. The sample collection
will be performed as much as possible by the participant herself at home at 9
timepoints. Samples drawn by healthcare professionals will be taken at 7
timepoints during home visits or regular contact moments with health care
professionals. There are no adverse events anticipated to be associated with
these procedures.
A. Deusinglaan 1
Groningen 9713 AV
NL
A. Deusinglaan 1
Groningen 9713 AV
NL
Listed location countries
Age
Inclusion criteria
Pregnant LifeLines participants
Exclusion criteria
Presence of one of the exclusion criteria will exclude a pregnant LL
participant from participation in this study:
- no informed consent obtained for this study
- not being able to fill in the questionnaires
- not being able to donate bio samples
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 | NL56068.042.15 |