NCT06544096

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 692 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 1 Day – 2 Months
• Healthy volunteers: Accepted

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.

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.

Conditions

• Infants

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2024-09-30
• Completion: 2025-01-15
• First posted: 2024-08-09
• Last updated: 2025-04-09

Locations

1 site across 1 country: China