Given the worldwide-observed rapid increase in the prevalence of allergic diseases, it is likely that environmental risk factors, including geographic area and lifestyle factors play a substantial role in the development of allergies and other…
ID
Source
Brief title
Condition
- Allergic conditions
- Respiratory tract infections
- Angioedema and urticaria
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. The occurrence of
• parent-reported allergic manifestations (e.g. symptoms suggestive of
wheeze/asthma, eczema/atopic dermatitis, allergic rhinitis/hayfever, food
allergy, pet allergy, house dust mite allergy).
• parent-reported doctor*s diagnosis of asthma, allergic rhinitis/hayfever,
eczema/atopic dermatitis, food allergy, pet allergy, house dust mite allergy.
• parent-reported manifestations of infections (e.g. symptoms suggestive of
respiratory tract, stomach, intestines, skin and urinary infections).
• parent-reported doctor*s diagnosis of respiratory tract, stomach, intestines,
skin and urinary infections.
2. The use of medications and/or a medical device (inhaler) to prevent or
relieve allergic manifestations, allergies and/or infections.
3. Number of days hospitalised for allergic manifestations, allergies, and/or
infections.
4. Number of visits to the emergency room for allergic manifestations,
allergies, and/or infections.
Secondary outcome
N/A
Background summary
This is an follow-up study of a randomised clinical trial, called TEMPO, in
which infants participated in their first year of life (a double-blind
randomised clinical trial investigating infant formula and human milk
consumption). Data from this TEMPO study will be re-used and linked to newly
collected data from the follow-up study, called Long-term Effect of Mixed Milk
Feeding study (LF effect MMF study or Tempo Follow-Up) study, that is described
in this protocol. Where it reads *first year of life*, the text refers to
information about the children that was previously collected in the original
TEMPO study.
Study objective
Given the worldwide-observed rapid increase in the prevalence of allergic
diseases, it is likely that environmental risk factors, including geographic
area and lifestyle factors play a substantial role in the development of
allergies and other atopic diseases. Infant nutrition is an important
modifiable lifestyle factor that influences the development and maturation
process of a child*s immune system, which may increase sensitization and
thereby the risk of atopic diseases in childhood. Adequate nutrition is also
important for the prevention of certain infections as nutrition can have an
immunomodulating function and thus influence susceptibility to infections, as
well as the course and outcome of the infections. The set of data of infants
from different countries from the TEMPO trial provides a unique opportunity to
gain further insights in the immune development of these infants beyond their
first year of life. It also offers the possibility to explore relationships
between recognized risk factors in allergy and immune system development (such
as mode of delivery, antibiotics use), laboratory parameter levels during the
first year of life and immune development (allergic manifestations, allergies
and infections) thereafter. The TEMPO Follow-Up study is unique because of the
existing detailed information including laboratory outcomes of the children in
their first year of life, its geographical distribution, and its fully virtual
and decentralised design.
Study design
TEMPO Follow-Up is a virtual and fully decentralised follow-up study of a
cohort of children who completed a nutritional randomised clinical trial in
infancy, called TEMPO study. It is a longitudinal prospective observational
cohort study in subjects without an intervention. The study is conducted
virtually using (smart)phone/computer-based subject recruitment, enrolment and
collection of study data. The participants are not required to visit a physical
study site and will not have any communication about their child*s health with
a health care provider. In the study only parent-reported information is
collected. This is done through completion of three-monthly digital
questionnaires that are accessed by the parents via an application that is
installed on a self-owned mobile device (smartphone or tablet) or via web-based
questionnaires using a personal computer. The parents will be asked whether
health outcomes such as asthma, hayfever, eczema, food allergy or certain
infections were diagnosed by a doctor, however these are not reviewed or
confirmed by a doctor. Also no data from medical records will be collected. The
children will be followed up until they are ten years of age.
Study burden and risks
As this is an observational cohort study without an (invasive) intervention
(e.g. no consumption of a study product, no bio-sampling, no intrusive
questions), the study presents no health risk. A high amount of new data will
be collected whilst keeping the burden of participation for the parents low by
the fully virtual and decentralised design (participation from home, digital
questionnaires).
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
Inclusion criteria
- Subject completed the final (12 months) visit in the TEMPO study.
- Parents agree that their contact details will be shared with a third party
for study purposes.
- Parents agree that data collected in the TEMPO study will be used in the
TEMPO Follow-Up study.
- Parents provide written informed consent for participation in the TEMPO
Follow-Up in accordance with local law.
Exclusion criteria
- Parents who do not have a smartphone, tablet or personal computer with
internet access.
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 |
|---|---|
| ClinicalTrials.gov | NCTnummernognietbekend |
| CCMO | NL81702.100.22 |