|- candidate number||13273|
|- NTR Number||NTR3626|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-aug-2012|
|- Secondary IDs||12-N-87 Atrium MC|
|- Public Title||Impact of the implementation of a double blind placebo controlled provocation elimination test in the management of (suspected) cow milk protein allergy (CMPA) in infants.|
|- Scientific Title||Impact of the implementation of evidence based practice in the management of (suspected) cow milk protein allergy (CMPA) in infants.|
|- hypothesis||Primary research question:|
What is the effect of the implementation of a dedicated clinic for the management of (suspected) cow milk protein allergy in infants referred from primary and secondary health care settings on:
1. Health care costs;
2. Satisfaction of customers and ofhealth care providers.
Secundary research questions:
1. What are the most common presenting symptioms of the patients and what is the evolution of the complaints during the course of the intervention?
2. Is there a difference in the manner of presentation as well as in their response to the intervention between patients referred from the primary and secondary health care settings?
3. What are the necessary steps required in the elimination of CMPA to significantly reduce the patients' symptoms and is there a difference in response between patients from the respective health care settings?
4. Does the introduction of telephone consultations contribute to more successful reintroductions to normal cow milk formulas following negative test results?
|- Healt Condition(s) or Problem(s) studied||Cow's milk allergy|
|- Inclusion criteria||1. Patients referred by a pediatrician, general practioner or infant welfare clinic physician (consultatiebureau art) with a suspected cow milk protein allergy;|
2. Patients younger under the age of 2 years;
3. Patients in whom there has never been a previous diagnosis of cow milk protein allergy.
|- Exclusion criteria||Patients in whom a previous diagnosis of cow milk protein allergy has been made and needs to undergo a repeat chalenge test or in whom there has been a proven tolerance to cow milk protein.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jul-2012|
|- planned closingdate||1-apr-2014|
|- Target number of participants||200|
|- Interventions||Implementation of a specialized cow milk protein clinic with a dedicated team of health care professionals. The aim is to reduce the costs involved in health care delivery process and improve the quality of service provided in the management of children with suspected CMPA.|
|- Primary outcome||Costs would be quantified based on:|
1. Costs incurred during hospital encounter which include. outpatient clinic visits, Shortstay admissions and telephone consultations;
2. Saved costs on the choice of infant formula;
3. Costs saved on consultation visits to the dietician.
Symptoms/complaints would be assessed with the aid of a questionnaire that would be used to evaluate the patients complaints at 4 different test moments (T1, T2, T3, T4).
The complaints/symptoms that would be measured include: vomitting, intestinal colic, crying, irritability, eczema, spugen, buikkrampen, huilen, onrust, diarrhoea or constipation, urticarial rash, coryza and conjuctivitis.
Patient satisfaction would be assessed in the following areas:
1. Contact with the nurse practitioner, pediatrician, ward nursing staff;
2. Quality of the care process;
3. Level of service.
Care providers satisfacion would be assessed in the following areas:
1. Satisfaction with the care process;
2. Perceived (dis)advantages of the care process.
|- Secondary outcome||Complaints would be scored with the help of the following measurement scales:|
1. Vomitting, intestinal colic, crying and irritability: 5-point likert scale;
2. Defaecation pattern: frequency and consistency.
|- Timepoints||Complaints would be registered with the help of a questionnaire at 4 different timepoints:|
T1: Parents fill in a questionaare at time of first short stay admission;
T2: Parents fill in a questionaare at time of second short stay admission;
T3: Questionnaire after first short stay admission over a 3 day period;
T4: Questionnaire after second short stay admission over a 3 day period.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| C. Janssen|
|- CONTACT for SCIENTIFIC QUERIES||MD, MHPE, PhD Jamiu O. Busari|
|- Sponsor/Initiator ||Atrium Medical Center, Heerlen|
(Source(s) of Monetary or Material Support)
|Mead Johnson Nutrition, Friso|
|- Brief summary||Cow milk protein allergy is one of the major causes of food allergy in infancy resulting in allergic reactions in about 2-3% of all children with atopy.
Despite the new insights on the etiology of CMPA however, the currently available in-vitro diagnostic methods are of limited diagnostic value in the detection of clinical relevant CMPA.
In practice, the screening of cow milk specific sensitivity can be determined by determining cow milk specific IgE in blood and/or conducting a skin test. However the only manner to determine cow milk allergy with 100% certainty would be to perform a cow milk challenge test.
This double blind placebo controlled elimination and provocation test is internationally accepted as the gold standard for diagnosing CMPA.
In the Netherlands, the diagnosis of most cases of suspected CMPA are unfortunately being made with the help of the open provocation diagnostic test. One of the reasons for this is that the procedure for conducting the double blind provocation test is time consuming and labor intensive to perform in a busy clinical practice, and is therefore only suitable for research purposes.
Furthermore, allergic reactions elicited using an open provocation test are difficult to reproduce when both the patient and the assesor are not blinded to the procedure. In such cases, several false positive diagnoses of CMPA are prone to be made.
It is generally accepted that double blind placebo controlled challenge tests are better than open provocation tests as a result of their increased diagnostic values and low percentage of false positive results. Moreover, studies have demonstrated that the acceptance rate by parents of children with suspected CMPA are higher when the diagnosis of CMPA is refuted using the double blind method.
This is important for the management and follow up in these cases as the chances of parents' complying to the re-introduction of normal infant formula would increase. This is an argument that calls for a structural implementation of double blind test in normal clinical practice in settings where these patients are regularly seen.
Based on the above reasons, we decided to design a health care process intervention for infants with suspected CMPA (in collaboration with infant welfare clinics in the region) in which the double blind challenge test as the gold standard of diagnosis was implemented. We designated a dedicated team of health care providers for this purpose who worked according to a 6-week protocol designed for this purpose. Our overall objective was to improve the efficiency and quality of care, reduce costs, and improve the patients experience of the service provided.
|- Main changes (audit trail)|
|- RECORD||30-aug-2012 - 7-okt-2012|