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)

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.

Study Overview

• Status: Completed
• Conditions: Cow's Milk Protein Allergy
• Intervention / Treatment: Other: Damira 2000 Infant formula

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Clínica privada Dr. Romera
  • Madrid, Spain
    • Fundación Jiménez Día
  • Andalucia
    • Córdoba, Andalucia, Spain
      • Hospital Quirónsalud de Córdoba
    • Sevilla, Andalucia, Spain
      • H. Virgen del Rocio
    • Sevilla, Andalucia, Spain
      • H. Virgen Macarena
    • Sevilla, Andalucia, Spain
      • Instituto Hispalense de Pediatria
  • Galicia
    • Orense, Galicia, Spain
      • Hospital Materno infantil de Ourense
    • Santiago De Compostela, Galicia, Spain
      • H. Clínico de Santiago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	To evaluate the effect of Damira 2000 on growth outcomes using weight and the related Z-scores weight-for-age (WAZ)	V1, V2 (4 months)
Height	To evaluate the effect of Damira 2000 on growth outcomes using height and the related Z-scores height-for-age (HAZ).	V1, V2 (4 months)
Weight for height and BMI	To evaluate the effect of Damira 2000 on growth outcomes using height and weight to calculate the Z-score weight-for-height (WHZ) and BMI for age (BAZ).	V1, V2, (4 months)
Head circumference	To evaluate the effect of Damira 2000 on growth outcomes using Head circumference and the related Z-Score Head circumference for age.	V1, V2 (4 months)

Collaborators and Investigators

• Sponsor: Lactalis

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2023
• Primary Completion (Actual): December 21, 2023
• Study Completion (Actual): December 21, 2023

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Estimated): February 22, 2024

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: DELISA2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No