Tolerance and Growth Outcomes in Children Diagnosed With Cow's Milk Protein Allergy and Prescribed an Extensively Hydrolyzed Casein Formula (Damira 2000©) in Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Lactalis
- 入组人数
- 61
- 试验地点
- 8
- 主要终点
- Tolerance
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Tolerance
时间窗: 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.
次要结局
- Weight(V1, V2 (4 months))
- Height(V1, V2 (4 months))
- Weight for height and BMI(V1, V2, (4 months))
- Head circumference(V1, V2 (4 months))