NCT04763512Completed
Clinical Study of Partially Hydrolysed Protein Infant Formula on Trans-epidermal Water Loss (TEWL)
Source: ClinicalTrials.gov · Last updated 27 Jun 2025
Brief summary (registry, in English)
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: * Intact Cow's Milk Protein Formula Group (CMFG) (n = 100) or * Partially Hydrolysed Whey Formula Group (pHFG) (n = 100).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 19 Nov 2020
- Start date
- 6 Jun 2021
- Primary completion date
- 19 Sept 2023
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT04763512
What you commit to
- Study type: Interventional
- Participants enrolled: 200
- From 6 Jun 2021 to the primary completion date, 19 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Infants currently using or have ever used partially hydrolysed protein formulas.
Other illness
- Known and diagnosed cow's milk protein allergy/intolerance.
- Infants who have ever used topical corticosteroids, calcineurin inhibitors and/or any other physician-recommended treatments for skin conditions after birth.
Other
- Infants who have been introduced to complementary foods.
Who the study is looking for
- 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.
Age in the registry: 35 days to 49 days · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Tonxin Pediatric Clinic Co. Ltd Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.