Determination of the (cost)effectiveness of the replacement of the expensive, risky and time-consuming food challenge test bythe Basophil Activation Test (BAT) for the diagnosis of an IgE-mediated cow*s milk allergy in children.
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The sensitivity, specificity, negative- and positive predictive value of the
BAT. Effectiveness of replacement of the food
challenge test by the BAT in diagnostic delay (and consequently quality of
life) and in costs of diagnostics and prescription of
hypoallergenic formula.
Secondary outcome
1) Cost reduction in diagnostics (replacement of the food challenge test by the
BAT) and cost reduction in prescription of
hypoallergenic formula due to reduction in diagnostic delay.
2) Effect of reduction in diagnostic delay and burden of diagnostics on patient
quality of life.
Background summary
Until now, cow*s milk allergy diagnosis is based on a food challenge test.
However, this food challenge test is expensive, time consuming (2-day hospital
stay), risky, stressful for children and their parents, with waiting lists of
several (2-6) months. This waiting time results in unnecessarily long-term use
of
expensive hypoallergenic milk formula (reimbursed by the health insurance).
Therefore, there is a great need to introduce a better and faster diagnostic
test for cow*s milk allergy diagnosis in standard care. The in vitro Basophil
Activation Test (BAT) is cheap, quick (result < 1 day, no waiting list), safe
for the child and is a reliable alternative for the food challenge test to
diagnose an IgE-mediated allergy. Although the potential added value of the BAT
is known for years, this test has not been implemented in guidelines yet. This
is due to the fact that more insight is required into
the (cost-)effectiveness regarding a) reduction in food challenge tests, b)
prescription of hypoallergenic milk formula and c) health gain
due to a shorter diagnostic work-up and reduction in risky food challenge
tests.
Study objective
Determination of the (cost)effectiveness of the replacement of the expensive,
risky and time-consuming food challenge test by
the Basophil Activation Test (BAT) for the diagnosis of an IgE-mediated cow*s
milk allergy in children.
Study design
The study design is a multicentre (n=17), prospective, cohort study. In this
study for all children both a BAT cow*s milk (index test) and a food challenge
test (reference test) will be performed. The results of both tests are compared
per individual and used for determination of the sensitivity, specificity, PPV
and NPV of the BAT. Change in quality of life of child/parents due to
knowledge of the allergic status of the child will be assessed by taking (Food
Allergy) Quality of Life Questionnaires before and after the food challenge
test. The period (in weeks) between the date of inclusion and the result of the
food challenge test will be recorded and used to calculate the theoretically
reduction in use of hypoallergenic cow*s milk formula.
Study burden and risks
The burden and risks of participating in this study are low as it only concerns
one extra blood collection and two times completing a short questionnaire.
Wagnerlaan 55
Arnhem 6815 AD
NL
Wagnerlaan 55
Arnhem 6815 AD
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria (all criteria must be met with in b. one or more symptoms):
a. Age 0-12 years
b. Suspected of cow's milk allergy with one or more of the following complaints
after intake of cow's milk:
- angioedema
- urticaria
- sneezing and rhinitis <2 hours after feeding
- sensation of swelling in the throat and/or difficulty swallowing <2 hours
after feeding
- voice change/hoarseness <2 hours after feeding
- cough <2 hours after feeding
- wheezing and/or shortness of breath <2 hours after feeding
- loss of consciousness <2 hours after feeding
- vomiting or abdominal pain or diarrhoea <2 hours after feeding in children <4
years only in combination with IgE-mediated complaints in other tracts
c. Placed on a waiting list for a hospital food challenge test
d. Blood draw for cow*s milk sIgE and BAT < 3 months before the food challenge
test
e. Signed informed consent parents/guardians
Exclusion criteria
Exclusion criteria (if one or more criteria are met, the child will be
excluded):
a. Age > 12 years
b. Suspicion of Food Protein-Induced Enterocolitis Syndrome (FPIES)
c. Eosinophilic esophagitis due to a cow's milk allergy
d. Suspected cow's milk allergy <4 years with crying and/or agitation and/or
eczema and/or abdominal pain and/or failure to
thrive and/or blood loss per anum and/or diarrhoea and/or reflux and/or
vomiting as the only manifestation of the allergy without
IgE-mediated symptoms in another organ system
e. Systemic immunosuppressant use
f. Other underlying chronic conditions (immunological, oncological, chromosomal
abnormalities).
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 | NL76893.091.21 |