Cow's Milk Protein Allergy
Conditions
Brief summary
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.
Interventions
OTHERFrisolac Gold Intensive HA
Regular medical care
Sponsors
Sprim Advanced Life Sciences
FrieslandCampina
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Months to 24 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Growth | Can be 2 weeks up to 2 months | * 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 (%) |
| Dermatological symptoms (SCORAD score) | Can be 2 weeks up to 2 months | The proportion of subjects with an 1-point improvement in their SCORAD intensity category in between 2 visits (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type of symptoms | Can be 2 weeks up to 2 months | Type of symptoms (e.g. crying, regurgitation, stool consistency, respiratory, enteropathies and colitis) (based on clinical diagnosis) |
| Number of symptoms | Can be 2 weeks up to 2 months | Number of symptoms (e.g. crying, regurgitation, stool consistency, respiratory, enteropathies and colitis) (based on clinical diagnosis) |
| Severity of symptoms | Can be 2 weeks up to 2 months | Severity of symptoms on first and second visit (based on clinical diagnosis) |
Countries
Mexico
Outcome results
None listed