To relate exposure markers of EDCs to health outcomes in children - in particular obesity and neurobehavioral disorders -, effect biomarkers, and other parameters via multiple regression and multivariate analysis, while taking into account relevant…
ID
Source
Brief title
Condition
- Other condition
- Developmental disorders NEC
Synonym
Health condition
Overgewicht
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint are health outcomes in children, in particular obesity
and neurobehavioral disorders at the age of 12 and 18 months, and 4 years, in
relation to exposure markers of EDCs in cord blood.
Secondary outcome
Secundary parameters include health outcomes such as birth weight, height,
waist circumference and head circumference. Furthermore outcomes such as
asthma, allergies, neurodevelopment, behaviour, sleep and crying will be taken
into account. All mentioned parameters will be related to exposure markers of
EDCs in cord blood.
Background summary
A certain class of chemicals has the ability to mimic hormones, disturbing
endocrine pathways. These chemicals are referred to as Endocrine Disrupting
Chemicals (EDCs). Animal studies have shown that prenatal exposure to some of
these EDCs increases body weight in offspring. EDCs have also been related to
the development of behavior disorders. However, prospective studies in humans
are lacking. It is hypothesized that increased prenatal exposure to EDCs
through nutrition and environmental dust is related to an increased risk of
obesity and neurobehavioral problems later in life.
Study objective
To relate exposure markers of EDCs to health outcomes in children - in
particular obesity and neurobehavioral disorders -, effect biomarkers, and
other parameters via multiple regression and multivariate analysis, while
taking into account relevant confounders and covariates.
Study design
This project is embedded in an European multidisciplinary study in which
several cohorts participate, in combination with results obtained from animal
studies. The current project is designed as an observational cohort study.
Study burden and risks
The LINC-study is an observational study which is primarily based on data
collected by regular health care provided by midwifery clinics, obstetricians
and youth health care. Furthermore cord blood, placenta, breast milk, urine,
vernix, meconium, saliva, a hand-wipe, mouth-wipe and back-wipe of the child,
and a dust and air sample will be collected, questionnaires will be
administered and head and waist circumference will be measured in children.
Collection of all biological samples is non-invasive, as are the measurement of
head and waist circumference and the administration of questionnaires. Some
questionnaires will cover sensitive topics, but anonymity is ensured. Therefore
no injury is expected.
Only pregnant women will be included, therefore the research group may be
regarded as group-related. As pregnancy is a normal, physiological process, it
is expected that participants will not consider it a problem to be part of this
group.
No compensation will be given to the mother-child pairs or to the midwifery
clinics. However the mother-child pairs may benefit from the information
collected regarding their health and lifestyle, for example regarding their
diets.
De Boelelaan 1085
Amsterdam 1081 HV
NL
De Boelelaan 1085
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Healthy women eligible for participation should be less than twelve weeks pregnant at their first visit
to the midwifery clinic. They should be able to fill out Dutch questionnaires. Incapacitated
subjects will not be asked to participate.
Exclusion criteria
Women with pre-eclampsia or twin pregnancies are excluded from further participation. Pre-eclampsia is defined as pregnancy-induced hypertension (1x diastolic pressure > 90
mmHg) in association with proteinuria (>0.3 g/day). Furthermore major congenital anomalies
at birth will be reason for exclusion.
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 | NL31941.029.10 |