The main objective of this study is to evaluate which urine collection method for non-toilet trained children is most suitable for exposure measurement to pesticides with respect tothe burden and convenience, including ease of use, for infants and…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
geen aandoeningen, namelijk urine verzamelen tbv biomonitoring
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: The main study parameter is the success rate
of each urine collection method. The success rate for one method is defined as
the number of valid samples collected and applicable for analysis.
Secondary outcome
The secondary study parameters are the least burdensome collection method and
the amount of urine collected.
Background summary
The application of pesticides in the vicinity of homes has raised public
concern regarding potential adverse health effects to people living close to
the agricultural land where these pesticides are applied. Residents are
particularly concerned about their child*s health and cancer. Many
epidemiological studies revealed associations between exposure to pesticides
and the occurrence of health effects such as reduced fertility, several forms
of cancer, especially leukaemia*s, and disorders of the central nervous system
(CNS). These findings were particularly uniform for leukaemia in the children
of farmers and Parkinson*s disease. The Dutch government has approved an
exposure study with the objective of *acquiring data on the potential exposure
of residents in agricultural areas where pesticides are used intensively*.
The Health Council reported that there should be a special focus on very young
children, because of strong associations between pesticide exposure and
childhood leukaemia, and young children are developing and maturating their
CNS, immune system and endocrine system from their birth up to their puberty.
Infants and children likely differ from adults in their exposure to
environmental chemicals as well as their susceptibility to chemicals, because
of various factors such as biometry, behaviour, diet and physiology, which will
result in higher exposures (per kilogram body weight) compared to adults and
older children. Furthermore, movement patterns of young children have a strong
effect on their exposure, and it would not be expected that the exposure of
potty-trained children is similar to that of infants. Examples of aberrant
behaviour of young children include playing on agricultural fields and grass
fields shortly after spraying, putting (soiled) hands and objects in their
mouth and crawling. In conclusion, there is a need to develop an appropriate
method to acquire pesticide exposure data, particularly for young children
(Gezondheidsraad, 2014).
The present protocol describes a pre-study to select a suitable urine
collection method for this (main) study where the exposure to pesticides will
be evaluated in residents, including young children.
Study objective
The main objective of this study is to evaluate which urine collection method
for non-toilet trained children is most suitable for exposure measurement to
pesticides with respect tothe burden and convenience, including ease of use,
for infants and their parents of each urine collection method. The secondary
objectives include the evaluation of whether there is a learning effect and
determination of the success rate of each method.
Study design
Study design: This pilot study is designed as a randomized cross-over trial
with repeated measurements.
Study burden and risks
Parents will be asked to collect urine of their child on twelve days in total
and each selected urine collection method will be used three times. A diary
should be kept on each day of urine collection. The risks in this research are
negligible since all urine collection methods are non-invasive. In addition,
the risk of adverse skin effects and allergic reactions is expected to be
negligible as there are no indications in previous studies that such effect
would occur.
Geert Grooteplein 10
Nijmegen 6526 GA
NL
Geert Grooteplein 10
Nijmegen 6526 GA
NL
Listed location countries
Age
Inclusion criteria
Parents with children wearing a diaper
Infant body weight > 2500 g
Exclusion criteria
A bladder infection or other illness or unwellness of the infant at the start of the study.
Pre-existing skin problems diagnosed by a medical doctor at the start of the study such as diaper dermatitis or eczema. Hypersensivity to disposable gloves, although latex-free gloves will be provided. Children with a history of an allergic reaction to adhesive tapes.
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 | NL51952.091.14 |