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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.

Impact of the implementation of evidence based practice in the management of (suspected) cow milk protein allergy (CMPA) in infants.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20340
Enrollment
200
Registered
2012-08-30
Start date
2012-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study is a process evaluation survey. Quantitative and qualitative data (mixed method) are used to evaluate the extent to which the implementation of a specialized clinic for the management of CMPA staffed with a dedicated team of care providers results in cost reduction in the delivery of service. In addition, we intend to asses if this specialized care process results in improved quality of care in children with (suspected) CMPA. Data collection commenced in July 2011 and runs through

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 qual

Sponsors

Department of pediatrics, Atrium medical center
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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. Satisfaction: 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

MeasureTime frame
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.

Contacts

Public ContactC. Janssen

Department of pediatrics Atrium medisch centrum Heerlen H. Dunantstraat 5

c.janssen@atriummc.nl+31 (0)45 5767131

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)