Status:
COMPLETED
Clinical Study of Partially Hydrolysed Protein Infant Formula on Trans-epidermal Water Loss (TEWL)
Lead Sponsor:
Société des Produits Nestlé (SPN)
Collaborating Sponsors:
Medidata Solutions
SAS Institute
Conditions:
Atopic Dermatitis
Skin Condition
Eligibility:
All Genders
35-49 years
Phase:
NA
Brief Summary
This is a single-centre, prospective, randomized, open-label, controlled trial of 200 infants 42±7 days of age. Subjects will be randomized to one of two open label feeding intervention group: * Inta...
Detailed Description
Atopic dermatitis (AD) affects 15 - 30% of children. Approximately 45% of these cases have an onset within the first 6 months of life and 60% develop within the first year (Bieber 2010). Besides envir...
Eligibility Criteria
Inclusion
- Infants 42± 7 days of age at enrolment (date of birth = age 0).
- Infants who have been born full-term gestational birth (≥ 37 completed weeks of gestation) and having a birth weight ≥ 2.5 kg and ≤ 4.5 kg.
- Parents /caregivers must agree to follow study procedures and recommended skincare routines, such as avoidance of moisturizers or other skincare products on the primary sites of interest.
- Parent(s) must have already independently elected before enrolment to formula feed and less than 30% of intake will be from breastmilk.
Exclusion
- Known and diagnosed cow's milk protein allergy/intolerance.
- Infants currently using or have ever used partially hydrolysed protein formulas.
- Infants who have ever used topical corticosteroids, calcineurin inhibitors and/or any other physician-recommended treatments for skin conditions after birth.
- Infants who have been introduced to complementary foods.
Key Trial Info
Start Date :
June 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04763512
Start Date
June 6 2021
End Date
November 2 2024
Last Update
June 27 2025
Active Locations (1)
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1
Shanghai Tonxin Pediatric Clinic Co. Ltd
Shanghai, Shanghai Municipality, China