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

NCT06273371 | Completed

• 1 other identifier: DELISA2023
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 8

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

Outcome Measures

Primary Outcomes (1)

• Tolerance

  The good tolerance of the currently on the market Damira 2000 formula will be evaluated by the number and percentage of patients with no (=0) immediate allergic reactions or intestinal reactions. Immediate reactions are defined as those allergic reactions occurring within 1 hour after intake. Intestinal reactions: delayed reactions (develop after ≥ 2 hours of consumption) involving gastrointestinal (GI) tract.

  Day 0 : V0 First visit to the hospital

Secondary Outcomes (4)

• Weight

  V1, V2 (4 months)

• Height

  V1, V2 (4 months)

• Weight for height and BMI

  V1, V2, (4 months)

• Head circumference

  V1, V2 (4 months)

Interventions

Damira 2000 Infant formula OTHER

100% extensive casein hydrolysate Infant formula

Eligibility Criteria

• Age: 0 Months - 12 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Infants aged from 0 to 12 months with cow's milk protein allergy

You may qualify if:

• 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;
• Patients under the age of 1 year at the time of cow's milk protein allergy diagnosis.
• Patients taken Damira 2000 for at least 4 months at the time of data extraction.
• 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).

You may not qualify if:

• Patients who used other infant formulae or breast milk in addition to the study product of interest during the retrospective study period.
• Premature children with a low birth-weight (\<2.5 kg).
• Patients diagnosed with a metabolic condition that impacts development and growth.
• 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.

Sponsors & Collaborators

• Lactalis: lead

Study Sites (8)

Hospital Quirónsalud de Córdoba

Córdoba, Andalusia, Spain

Location

H. Virgen del Rocío

Seville, Andalusia, Spain

Location

H. Virgen Macarena

Seville, Andalusia, Spain

Location

Instituto Hispalense de pediatría

Seville, Andalusia, Spain

Location

Hospital Materno infantil de Ourense

Ourense, Galicia, Spain

Location

H. Clínico de Santiago

Santiago de Compostela, Galicia, Spain

Location

Clínica privada Dr. Romera

Madrid, Spain

Location

Fundación Jiménez Día

Madrid, Spain

Location

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 22, 2024
• Study Start: December 12, 2023
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8)