The Journey of Children With Cow's Milk Protein Allergy in Mexico.

Study Overview
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Brief Summary
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To gain insights on the application, use and effectiveness of Frisolac Gold Intensive HA and Frisolac Gold PEP AC with reference to improvement of CMPA symptoms and to determine the methodology used by Mexican Health Care Professionals (HCPs) in the clinical practice (i.e. diagnosis and dietary management) of CMPA in Mexican children (≤24 months) diagnosed with or suspected of CMPA.

Official Title
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A Retrospective and Comparative Study on the Journey of Children With Cow´s Milk Protein Allergy in Mexico: Current Practice in Allergy Management in Mexican Children Aged ≤24 Months

Conditions
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Cow's Milk Protein Allergy

Intervention / Treatment
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* Other: Frisolac Gold Intensive HA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with electronic/physical medical records that contain sufficient data to answer the primary question (i.e. data on growth and dermatological symptoms (based on the SCORAD score) at diagnosis and follow up data of at least 2 months or successful completion of therapy according to the PI (whichever comes first). Subjects ≤24 months of age at the moment of suspected or diagnosed CMPA with records available between January 2016 to September 2020. Subjects prescribed with Frisolac Gold Intensive HA and/or Frisolac Gold PEP AC for the dietary management of their CMPA symptoms. Exclusion Criteria: Subjects using other formula products/breast milk alongside Frisolac Gold Intensive HA or Frisolac Gold PEP AC during the time of their participation in the study. Premature children, or children with low birth-weight (weight at birth <2.5 kg). Subjects diagnosed with a metabolic condition that impacts development and growth. Subjects diagnosed with a congenital condition and/or with prior or current disease that in the opinion of the PI could potentially interfere with their participation in the study.

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Frisolac Gold Intensive HA|Regular medical care|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth | the proportion of subjects with weight gain compared to the previous visit (%) the proportion of subjects with height gain compared to the previous visit (%) the proportion of subjects with both weight and height gain compared to the previous visit (%) | Can be 2 weeks up to 2 months | 
| Dermatological symptoms (SCORAD score) | The proportion of subjects with an 1-point improvement in their SCORAD intensity category in between 2 visits (%) | Can be 2 weeks up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of symptoms | Type of symptoms (e.g. crying, regurgitation, stool consistency, respiratory, enteropathies and colitis) (based on clinical diagnosis) | Can be 2 weeks up to 2 months | 
| Number of symptoms | Number of symptoms (e.g. crying, regurgitation, stool consistency, respiratory, enteropathies and colitis) (based on clinical diagnosis) | Can be 2 weeks up to 2 months | 
| Severity of symptoms | Severity of symptoms on first and second visit (based on clinical diagnosis) | Can be 2 weeks up to 2 months |