Tolerance and Growth Outcomes in Children Diagnosed With Cow's Milk Protein Allergy and Prescribed an Extensively Hydrolyzed Casein Formula (Damira 2000©) in Spain (DELISA)

Lactalis

Status: Completed

Conditions: Cow's Milk Protein Allergy

Treatments: Other: Damira 2000 Infant formula

Study type: Observational

Funder types: Industry

Identifiers

NCT06273371

DELISA2023

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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.