Early Supplementation for Cow's Milk Allergy Prevention

Launched by MEDICAL UNIVERSITY OF WARSAW · Oct 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether introducing different types of cow's milk formulas or human milk soon after birth can help prevent cow's milk allergy (CMA) in infants. CMA is a common allergy that can affect a child's diet and overall quality of life. The researchers want to find out if giving healthy newborns cow's milk formula, amino acids formula, donor human milk, or specially processed donor milk shortly after birth can lower the chance of developing this allergy later on.

To be eligible for this trial, infants must be healthy, full-term babies born to mothers who plan to exclusively breastfeed for the first six months, and they should be enrolled within 24 hours of birth. Infants with serious health issues or those whose parents plan to use formula feeding are not eligible. Participants will receive one of the study formulas and will be monitored throughout the trial to see how their bodies respond. This research aims to provide clearer guidelines on how early exposure to cow's milk proteins might help protect against CMA, ultimately benefiting many families.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 1. Healthy newborns of mothers who express the intention to exclusively breastfeed for first 6 months of infant's life
• • 2. Full-term infants (defined as gestational age of at least 37 weeks)
• • 3. Infant birth weight at least 2500 g and ≤ 4500 g
• • 4. Age at enrolment \<24 h of life
• • 5. Regardless of any atopic condition in parents
• • 6. Written informed consent of the caregiver
• Exclusion criteria:
• • 1. Infants of parents who intend to partially or fully formula feed
• • 2. 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
• • 3. Contradictions to exclusive breastfeeding
• • 4. Multiple pregnancy