Application Evaluation of Newborn Home Skin Care Management System Under the Service of "WeChat Platform+Health Care"
Evaluation of the Effectiveness of a Neonatal Home Skin Care Guidance Based on We-chat: A Cluster-Randomized Controlled Trial
1 other identifier
interventional
692
1 country
1
Brief Summary
Through the establishment of the newborn home skin care management system under the service of "WeChat platform+health care", the investigators focus on the common skin problems of newborns at home, push health education materials through the system, teach parents the methods and details of home skin care, and evaluate the effect of the system on reducing the incidence of newborn home skin problems and the prognosis of home skin problems through cluster randomized controlled research.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2024
CompletedStudy Start
First participant enrolled
August 1, 2024
CompletedFirst Posted
Study publicly available on registry
August 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2025
CompletedApril 9, 2025
April 1, 2025
2 months
July 29, 2024
April 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of diaper dermatitis in newborns at home
The proportion of people with diaper dermatitis in the total number of people in the study.The diagnosis of diaper dermatitis is based on any rash in the diaper area reported by parents.
Within two months after birth
Secondary Outcomes (3)
Incidence rate of neonatal home atopic dermatitis (AD)
Within two months after birth
Rate of Hospital Visits for Skin Problems
Within two months after birth
Parental Knowledge of Home Skincare
Within two months after birth
Study Arms (2)
the control group
ACTIVE COMPARATORRoutine health education
Using"WeChat platform+health care" group
EXPERIMENTALUse"WeChat platform+health care"
Interventions
The study will implement the WeChat-based Neonatal Home Skin Care Management System, designed based on neonatal skin characteristics and evidence-based care guidelines. The intervention materials included a WeChat platform functional module (comprising a newborn information registration interface, online consultation, and questionnaire features) along with standard educational brochures used in the control group. During hospitalization, study group healthcare providers will deliver standard health education (identical to the control group) while additionally guiding mothers through platform registration and data entry, with demonstrations of system functionality. Post-discharge, the system automatically will deliver stage-appropriate skin care recommendations based on neonatal age with read reminders prompting parental engagement. Parents can access educational materials or submit queries at any time, while researchers utilize the platform for survey distribution.
When the parturient is discharged from the hospital, the medical staff of the control unit will give the parturient health education about the discharge of the newborn. The contents of the education include neonatal jaundice, umbilical care, vaccination, 42-day follow-up, breastfeeding and so on, which are not included in the system.
Eligibility Criteria
You may qualify if:
- Newborns born in normal delivery (gestational age ≧35w)
- Newborns' parents can cooperate, have certain learning, reading and understanding abilities, and have the ability to care for newborns
- Voluntary participation in this study.
You may not qualify if:
- Newborns requiring hospitalization.
- Newborns diagnosed with congenital skin diseases.
- The newborn mother has mental illness.
- The newborn mother has a serious illness and needs hospitalization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
Related Publications (1)
Yang T, Chen Y, Dou Y, Qiu M, Wang Y, Jiang S, Hu X. Parent-guided home skin care for infants via a WeChat platform: a study protocol for a cluster randomized controlled trial. Trials. 2025 Oct 31;26(1):458. doi: 10.1186/s13063-025-09186-x.
PMID: 41174684DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hu Xiaojing, PhD
Children's Hospital of Fudan University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2024
First Posted
August 9, 2024
Study Start
August 1, 2024
Primary Completion
September 30, 2024
Study Completion
January 15, 2025
Last Updated
April 9, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share