Clinical trial NCT04596059: The Journey of Children With Cow's Milk Protein Allergy in Mexico.
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cow's Milk Protein Allergy
Lead sponsor: FrieslandCampina
Sponsor class: INDUSTRY
Collaborators: name: Sprim Advanced Life Sciences
First posted: 2020-10-22
Enrollment: 79
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mexican children (≤24 months) diagnosed with or suspected of CMPA.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Growth
timeFrame: Can be 2 weeks up to 2 months
measure: Dermatological symptoms (SCORAD score)
timeFrame: Can be 2 weeks up to 2 months
Secondary outcomes:
measure: Type of symptoms
timeFrame: Can be 2 weeks up to 2 months
measure: Number of symptoms
timeFrame: Can be 2 weeks up to 2 months
measure: Severity of symptoms
timeFrame: Can be 2 weeks up to 2 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Clinica San Antonio
city: Pachuca
country: Mexico
facility: Clínica de Alergia Pediátrica
city: Pachuca
country: Mexico
facility: Consultorio de Pediatria
city: Pachuca
country: Mexico
facility: Hospital del Niño DIF
Study officials:
affiliation: Clínica de Alergia Pediátrica, México
name: Rosa E Huerta Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinica San Antonio, Mexico
name: Benjamin Zepeda Ortega, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Niño DIF Hildago, Mexico; Consultorio de Pediatría Pachuca, Mexico
name: Marlene Ruiz Castillo, MD
role: PRINCIPAL_INVESTIGATOR
References: