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

NCT04763512 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-06-27

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Intact Cow's Milk Protein Formula

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.

DIETARY_SUPPLEMENT

Partially Hydrolysed Whey Formula

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.

Sponsors & Collaborators

  • Medidata Solutions

    collaborator INDUSTRY

  • SAS Institute

    collaborator INDUSTRY

  • Veeva Systems

    collaborator INDUSTRY

  • Cognizant Technology Solutions AG

    collaborator UNKNOWN

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Principal Investigators

  • Jie Shao, Dr. · Shanghai Tonxin Pediatric Clinic Co. Ltd

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Days
Max Age
49 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-06
Primary Completion
2023-09-19
Completion
2024-11-02

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04763512 on ClinicalTrials.gov