Application Evaluation of Newborn Home Skin Care Management System Under the Service of "WeChat Platform+Health Care"

April 7, 2025 updated by: Children's Hospital of Fudan University

Evaluation of the Effectiveness of a Neonatal Home Skin Care Guidance Based on We-chat: A Cluster-Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, the cluster randomization method is used, and eight centers are assigned to the experimental group or the control group according to the ratio of 1:1. Randomization plan is made by independent statistical team in statistical software: by creating random seed numbers and sorting them, the intervention plan distribution of each center is determined. The outcome evaluator and the statistical analysis team will not know the grouping situation of each center.

In this study, there are 4 centers in the experimental group and 4 centers in the control group. Sample size calculation is based on the main outcome index: the incidence of diaper dermatitis in newborns at home.

Study Type

Interventional

Enrollment (Actual)

692

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Children's Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: the control group
Routine health education
Behavioral: control group (routine health education)
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.
Experimental: Using"WeChat platform+health care" group
Use"WeChat platform+health care"
Behavioral: intervention group (WeChat platform + healthcare)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of diaper dermatitis in newborns at home
Time Frame: Within two months after birth
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of neonatal home atopic dermatitis (AD)
Time Frame: Within two months after birth
The proportion of people with atopic dermatitis (AD) in the total number of people in the study.The subjects reported by parents are itching, typical morphology and location (flexor dermatitis) or atypical morphology and location accompanied by xeroderma and chronic or recurrent course of disease; Have the above three items at the same time to diagnose.
Within two months after birth
Rate of Hospital Visits for Skin Problems
Time Frame: Within two months after birth
The rate of parent-initiated hospital visits for infant skin problems was calculated as the total number of visits for skin issues divided by the total number of newborns investigated during the study period.
Within two months after birth
Parental Knowledge of Home Skincare
Time Frame: Within two months after birth
Parental knowledge of home skincare was assessed using questionnaire scores on skin management knowledge
Within two months after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Investigators

  • Principal Investigator: Hu Xiaojing, PhD, Children's Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

January 15, 2025

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2024/6/7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infants

Clinical Trials on control group (routine health education)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe