Tolerance and Growth Outcomes in Children Diagnosed With Cow's Milk Protein Allergy and Prescribed an Extensively Hydrolyzed Casein Formula (Damira 2000©) in Spain
- Conditions
- Cow's Milk Protein Allergy
- Registration Number
- NCT06273371
- Lead Sponsor
- Lactalis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
- 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).
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tolerance Day 0 : V0 First visit to the hospital 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.
- Secondary Outcome Measures
Name Time Method Weight V1, V2 (4 months) To evaluate the effect of Damira 2000 on growth outcomes using weight and the related Z-scores weight-for-age (WAZ)
Height V1, V2 (4 months) To evaluate the effect of Damira 2000 on growth outcomes using height and the related Z-scores height-for-age (HAZ).
Weight for height and BMI V1, V2, (4 months) 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).
Head circumference V1, V2 (4 months) To evaluate the effect of Damira 2000 on growth outcomes using Head circumference and the related Z-Score Head circumference for age.
Trial Locations
- Locations (8)
Hospital Quirónsalud de Córdoba
🇪🇸Córdoba, Andalucia, Spain
H. Virgen del Rocío
🇪🇸Sevilla, Andalucia, Spain
H. Virgen Macarena
🇪🇸Sevilla, Andalucia, Spain
Instituto Hispalense de pediatría
🇪🇸Sevilla, Andalucia, Spain
Hospital Materno infantil de Ourense
🇪🇸Orense, Galicia, Spain
H. Clínico de Santiago
🇪🇸Santiago De Compostela, Galicia, Spain
Clínica privada Dr. Romera
🇪🇸Madrid, Spain
Fundación Jiménez Día
🇪🇸Madrid, Spain
Hospital Quirónsalud de Córdoba🇪🇸Córdoba, Andalucia, Spain