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

NCT ID: NCT06273371

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-12
• Study Completion Date: 2023-12-21

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.

Conditions

Cow's Milk Protein Allergy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Damira 2000 Infant formula

100% extensive casein hydrolysate Infant formula

Intervention Type: OTHER

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.

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lactalis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Quirónsalud de Córdoba

Córdoba, Andalusia, Spain

H. Virgen del Rocío

Seville, Andalusia, Spain

H. Virgen Macarena

Seville, Andalusia, Spain

Instituto Hispalense de pediatría

Seville, Andalusia, Spain

Hospital Materno infantil de Ourense

Ourense, Galicia, Spain

H. Clínico de Santiago

Santiago de Compostela, Galicia, Spain

Clínica privada Dr. Romera

Madrid, , Spain

Fundación Jiménez Día

Madrid, , Spain

Countries

Spain

Other Identifiers

DELISA2023

Identifier Type: -

Identifier Source: org_study_id