Clinical trial NCT06273371: Tolerance and Growth Outcomes in Children Diagnosed With Cow's Milk Protein Allergy and Prescribed an Extensively Hydrolyzed Casein Formula (Damira 2000©) in Spain
Official title: Tolerance and Growth Outcomes in Children Diagnosed With Cow's Milk Protein Allergy and Prescribed an Extensively Hydrolyzed Casein Formula (Damira 2000©) in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cow's Milk Protein Allergy
Lead sponsor: Lactalis
Sponsor class: INDUSTRY
First posted: 2024-02-22
Enrollment: 61
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants aged from 0 to 12 months with cow's milk protein allergy

Brief summary: Damira 2000© is a 100% extensive casein hydrolysate (eHCF). It is formulated to help reverse growth retardation as a result of cow's milk proteins allergy (CMPA), to be well tolerated and to help improve symptoms.Damira 2000 is indicated for allergy/intolerance to cow's milk proteins, atopic dermatitis secondary to CMPA, intestinal malabsorption processes and prevention of allergy/intolerance to cow's milk proteins.The study aimed at evaluating the tolerance of Damira 2000 in a cohort of children with CMPA.


Eligibility criteria: Inclusion Criteria:

1. Patients with a diagnosis of allergy to cow's milk protein (CMPA): either confirmed through a placebo-controlled food challenge (DBPCFC) or highly suspected based on specific suggestive symptoms;
2. Patients under the age of 1 year at the time of cow's milk protein allergy diagnosis.
3. Patients taken Damira 2000 for at least 4 months at the time of data extraction.
4. Patients with information available on child growth (weight and height) and the following anthropometric indices at diagnosis and for at least 2 follow-up visits after first hospital visit/4 months\*: Z-scores for weight-for-age (WAZ), height-for-age (HAZ), weight-for-height (WHZ) and body mass index (BMI)-for-age (BAZ).

Exclusion Criteria:

1. Patients who used other infant formulae or breast milk in addition to the study product of interest during the retrospective study period.
2. Premature children with a low birth-weight (\<2.5 kg).
3. Patients diagnosed with a metabolic condition that impacts development and growth.
4. Patients diagnosed with a congenital condition and/or with prior or current disease that in the opinion of the investigator could potentially interfere with the aim of the study.

Primary outcomes:
measure: Tolerance
timeFrame: Day 0 : V0 First visit to the hospital
Secondary outcomes:
measure: Weight
timeFrame: V1, V2 (4 months)
measure: Height
timeFrame: V1, V2 (4 months)
measure: Weight for height and BMI
timeFrame: V1, V2, (4 months)
measure: Head circumference
timeFrame: V1, V2 (4 months)
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Quirónsalud de Córdoba
state: Andalucia
city: Sevilla
country: Spain
facility: H. Virgen del Rocío
state: Andalucia
city: Sevilla
country: Spain
facility: H. Virgen Macarena
state: Andalucia
city: Sevilla
country: Spain
facility: Instituto Hispalense de pediatría
state: Andalucia
city: Orense
country: Spain
facility: Hospital Materno infantil de Ourense
state: Galicia
city: Santiago De Compostela
country: Spain
facility: H. Clínico de Santiago
state: Galicia
city: Madrid
country: Spain
facility: Clínica privada Dr. Romera
city: Madrid
country: Spain
facility: Fundación Jiménez Día
Study officials:
References: