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

Fudan University

Status: Completed

Conditions: Infants

Treatments: Behavioral: intervention group (WeChat platform + healthcare); Behavioral: control group (routine health education)

Study type: Interventional

Funder types: Other

Identifiers

NCT06544096

2024/6/7

Details and patient eligibility

About

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.

Full 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.

Enrollment: 692 patients

Sex: All

Ages: 1 day to 2 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

692 participants in 2 patient groups

the control group

Active Comparator group

Description:

Routine health education

Treatment:

Behavioral: control group (routine health education)

Using"WeChat platform+health care" group

Experimental group

Description:

Use"WeChat platform+health care"

Treatment:

Behavioral: intervention group (WeChat platform + healthcare)