Clinical Study of Partially Hydrolysed Protein Infant Formula on Trans-epidermal Water Loss (TEWL)

NCT04763512 | Completed

• 1 other identifier: 20.16.INF
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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:

• Intact Cow's Milk Protein Formula Group (CMFG) (n = 100) or
• Partially Hydrolysed Whey Formula Group (pHFG) (n = 100).

Conditions

Atopic Dermatitis; Skin Condition

Keywords

atopic dermatitis development; trans-epidermal water loss; allergy; growth patterns; quality of life; gut comfort; partially hydrolysed whey

Outcome Measures

Primary Outcomes (1)

• Skin barrier function

  Change in Trans-epidermal water loss (TEWL)

  Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)

Secondary Outcomes (11)

• Weight

  Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only

• Length

  Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only

• Head Circumference

  Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only

• Infant health-related quality of life

  Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only

• Infant health-related quality of life

  Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only

Study Arms (2)

Intact Cow's Milk Protein Formula Group (CMFG)

EXPERIMENTAL

All enrolled subjects will be fed Stage 1 CMF libitum for 4 months. Thereafter, they will discontinue study formula and complete the study.

Dietary Supplement: Intact Cow's Milk Protein Formula

Partially Hydrolysed Whey Formula Group (pHFG)

EXPERIMENTAL

All enrolled subjects will be fed Stage 1 pHF libitum for 4 months. Thereafter, they will switch to Stage 2 pHF at age 6 months (Study Month 4) and to Stage 3 pHF at age 12 months (Study Month 9) and continue until age 18 months (Study Month 15). Thereafter, they will discontinue study formula and complete the study.

Dietary Supplement: Partially Hydrolysed Whey Formula

Interventions

Intact Cow's Milk Protein Formula DIETARY_SUPPLEMENT

Study product will be provided as powder, reconstituted with water by parents/caregivers according to label instructions, and consumed orally. Study participants will continue this feeding regimen for 4 months.

Intact Cow's Milk Protein Formula Group (CMFG)

Partially Hydrolysed Whey Formula DIETARY_SUPPLEMENT

Study product will be provided as powder, reconstituted with water by parents/caregivers according to label instructions, and consumed orally. Study participants will continue this feeding regimen for 16 months.

Partially Hydrolysed Whey Formula Group (pHFG)

Eligibility Criteria

• Age: 35 Days - 49 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Medidata Solutions: collaborator
• SAS Institute: collaborator
• Veeva Systems: collaborator
• Cognizant Technology Solutions AG: collaborator

Study Sites (1)

Shanghai Tonxin Pediatric Clinic Co. Ltd

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Skin Diseases; Hypersensitivity

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Jie Shao, Dr.

  Shanghai Tonxin Pediatric Clinic Co. Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: February 21, 2021
• Study Start: June 6, 2021
• Primary Completion: September 19, 2023
• Study Completion: November 2, 2024
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

CN (1)