Early Supplementation for Cow's Milk Allergy Prevention (ESCAPE-PL)

Medical University of Warsaw

Status: Begins enrollment in 1 month

Conditions: Food Allergy; Cow's Milk Allergy

Treatments: Other: Amino-acid formula [AAF]; Other: High-pressure processed "pascalized" donor human milk [DHM-P]; Other: Cow's milk formula [CMF]; Other: Donor human milk [DHM]

Study type: Interventional

Funder types: Other

Identifiers

NCT06652698

ABM30

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: Under 24 hours old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,000 participants in 4 patient groups

CMF

Experimental group

Treatment:

Other: Cow's milk formula [CMF]

AAF

Experimental group

Treatment:

Other: Amino-acid formula [AAF]

DHM

Experimental group

Treatment:

Other: Donor human milk [DHM]

DHM-P

Experimental group

Treatment:

Other: High-pressure processed "pascalized" donor human milk [DHM-P]