Cow's Milk Protein Allergy
Conditions
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.
Interventions
OTHERDamira 2000 Infant formula
100% extensive casein hydrolysate Infant formula
Sponsors
Lactalis
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Months to 12 Months
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Outcome results
None listed