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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Damira 2000 Infant formula | Other | 100% extensive casein hydrolysate Infant formula |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Infants aged from 0 to 12 months with cow's milk protein allergy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Quirónsalud de Córdoba | Córdoba | Andalusia | Spain | |||
| H. Virgen del Rocío |
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| 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) |
| 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 |
| ID | Term |
|---|---|
| D016269 | Milk Hypersensitivity |
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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