Skip to main content
OpenTrials
Completed

NCT Number: NCT06544096

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infants

Age range

1 day–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

intervention group (WeChat platform + healthcare)

Behavioral

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.

control group (routine health education)

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.