Early Supplementation for Cow's Milk Allergy Prevention in Breastfed Infants in Poland (ESCAPE-PL): a Protocol for Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- A cumulative incidence of cow's milk allergy confirmed by open oral food challenge
研究概览
简要总结
Cow's milk allergy (CMA) is a common food allergy in infants and young children that can have a significant impact on the individual and their family due to dietary restrictions, risk of nutritional deficiencies, social limitations, and decreased quality of life. It also represents a financial burden for families and healthcare resources.
There is an ongoing debate about the significance of early exposure to cow's milk proteins within hours or days after birth and its relationship to the risk of developing CMA later in life. Current recommendations for early introduction of cow's milk proteins in infants who cannot be breastfed vary and are inconsistent due to a lack of clear evidence. This knowledge gap underscores the need for further research to provide a definitive understanding of the relationship between early exposure to cow's milk proteins and the development of CMA, which will ultimately inform evidence-based prevention strategies to improve the health and well-being of affected individuals and their families.
This trial aims to investigate whether early supplementation with various nutritional interventions (cow's milk formula [CMF], amino acids formula [AAF], donor human milk [DHM], or high-pressure processed "pascalized" donor human milk [DHM-P]) could serve as an effective strategy for the primary prevention of CMA in breastfed neonates.
This study is an open-label randomized, controlled, head-to-head trial with four parallel arms and allocation 1:1:1:1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy newborns of mothers who express the intention to exclusively breastfeed for first 6 months of infant's life
- •Full-term infants (defined as gestational age of at least 37 weeks)
- •Infant birth weight at least 2500 g and ≤ 4500 g
- •Age at enrolment <24 h of life
- •Regardless of any atopic condition in parents
- •Written informed consent of the caregiver
排除标准
- •Infants of parents who intend to partially or fully formula feed
- •Serious congenital anomalies or any other medical condition that would preclude the consumption of any of the study formulas, or interfere with nutrition or growth
- •Contradictions to exclusive breastfeeding
- •Multiple pregnancy
结局指标
主要结局
A cumulative incidence of cow's milk allergy confirmed by open oral food challenge
时间窗: At 4-6 and 12 months of age
次要结局
- Total and true protein concentrations in human milk samples (g/100 mL)(at 4-14 days postpartum and 6 months of age)
- Fat concentration in human milk samples (g/100 mL)(at 4-14 days postpartum and 6 months of age)
- A cumulative incidence of feeding difficulties who will be screened with The Montreal Children's Hospital Feeding Scale (MCH-FS scale)(at 6 and 12 months of age)
- Human milk energy value (kcal/100 mL)(at 4-14 days postpartum and 6 months of age)
- Lactose concentration in human milk samples (g/100 mL)(at 4-14 days postpartum and 6 months of age)
- A cumulative incidence of sensitization to cow's milk protein (cut-off levels for specific IgE level ≥0.35 allergen units [UA/mL] and ≥3 mm of wheal size in the skin prick test against cow's milk(at 6 and 12 months of age)
- A point prevalence of cow's milk allergy confirmed by open oral food challenge(at 4-6, and 12 months of age)
- An incidence of sensitization to cow's milk protein (cut-off levels for specific IgE level ≥0.35 allergen units [UA/mL] against cow's milk)(at 4-6, and 12 months of age)
- In a subgroup of children with confirmed cow's milk allergy, the percentage of children with tolerance acquisition to cow's milk(at 9 and/or 12 months)
- Percentage of children who received a full 3-day nutritional supplementation (3x10 ml according to the randomization) and then were exclusively or predominantly breastfed until 4 months of age(Up to 4 month of age)
- A total score in the Cow's Milk-related Symptom Score (CoMiSS)(at 4-6 and 12 months of age)
- Percentage of children exclusively breastfed(at 4 and 6 months of age)
- Percentage of children with mixed feeding(at 4 and 6 months of age)
- Change in Body Mass Index (BMI)-for-age z-score(at 4, 6 and 12 months of age)
- Change in length-for-age z-score(at 4, 6 and 12 months of age)
- Adverse events related to the nutritional intervention (according to the randomization)(up to 12 months of age)
- A cumulative incidence of atopic dermatitis (defined as meeting the UK Working Party diagnostic Criteria)(at 6 and 12 months of age)
- A cumulative incidence of allergic rhinitis (confirmed by study physician)(at 6 and 12 months of age)
- Dry mass content g/100 mL(at 4-14 days postpartum and 6 months of age)
- IgA-anty CMA concentration in human milk samples (pg/mL)(at 4-14 days postpartum)
- IL-1B, IL-6, IL-10, and TGF-beta concentrations in human milk samples (pg/mL)(at 4-14 days postpartum)