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 Type
OBSERVATIONAL
Enrollment
61
100% extensive casein hydrolysate Infant formula
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
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.
Time frame: Day 0 : V0 First visit to the hospital
Weight
To evaluate the effect of Damira 2000 on growth outcomes using weight and the related Z-scores weight-for-age (WAZ)
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: V1, V2 (4 months)
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