To determine the relative risk of developing atopic dermatitis in infants fed a study formula based on whole goat milk compared to infants a study formula based on cow milk protein.
Who can participate
Age range0 Days – 90 Days
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Having obtained written informed consent (signed and dated) of the child's parent(s)/caregiver(s), indicating that the child's parent(s)/caregiver(s) has/have been informed of all pertinent aspects of the study
* Born full term (≥37 weeks +0 days and ≤ 41 weeks +6 days of gestation)
* Age at enrolment \< 3 months of age (\<90 days)
* Birth weight ≥2.5 kg and ≤4.5 kg
* Born from a singleton pregnancy
* Child's parent(s)/caregiver(s) is/are of legal age of consent
* The child's parent(s)/caregiver(s) have sufficient local language skills to understand the study information, the informed consent, and to comply with the study procedure
* The child's parent(s)/caregiver(s) is/are willing and deemed able to fulfil the requirements of the study protocol and procedures
* Mother has expressed the intention to partially (in combination with breastfeeding) or fully formula-feed
Exclusion Criteria:
* Diagnosed disorder considered to interfere with nutrition, growth or development of the immune system
* Participation of the child in any other interventional trial or participation of the mother in any intervention trial with child follow-up
* Infant has a doctor's diagnosis of atopic dermatitis or a severe widespread skin condition prior to randomization that would make the detection or assessment of atopic dermatitis difficult
* Infant has consumed an infant formula for more than 4 weeks prior to enrolment
* Cow milk allergy or intolerance
* Institutionalized infa…
What they're measuring
1
Cumulative incidence of atopic dermatitis up to the age of 12 months