Early Supplementation for Cow's Milk Allergy Prevention
- Conditions
- Food AllergyCow's Milk Allergy
- Registration Number
- NCT06652698
- Lead Sponsor
- Medical University of Warsaw
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method A cumulative incidence of cow's milk allergy confirmed by open oral food challenge At 4-6 and 12 months of age
- Secondary Outcome Measures
Name Time Method 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 Total score range from 14 to 98, score of 46 or higher indicates feeding difficulties.
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 Tolerance acquisition to cow's milk will be assessed by subsequent OFC with baked milk (in the form of biscuit or muffin); if baked milk is tolerated, the assessment of tolerance acquisition will be continued with the use of milk ladder.
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 The total CoMiSS score ranges from 0 to 33, a score of ≥10 indicates CMA.
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 weight and length will be checked each month in a telephone interview or parental report, or during follow-up visit assessed by study physician; change in mean value will be assessed between baseline and each time point
Change in length-for-age z-score at 4, 6 and 12 months of age length will be checked each month in a telephone interview or parental report, or during follow-up visit assessed by study physician; change in mean value will be assessed between baseline and each time point
Adverse events related to the nutritional intervention (according to the randomization) up to 12 months of age defined as any harmful events that may occur during the trial; the process of decision whether an adverse event is related to the intervention (attribution) will be made by the non-blinded principal investigator
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
Trial Locations
- Locations (1)
Medical University of Warsaw
🇵🇱Warsaw, Masovian, Poland