Infants
Conditions
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.
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.
Interventions
BEHAVIORALintervention 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.
BEHAVIORALcontrol 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.
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 2 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of diaper dermatitis in newborns at home | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of neonatal home atopic dermatitis (AD) | 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. |
| Rate of Hospital Visits for Skin Problems | 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. |
| Parental Knowledge of Home Skincare | Within two months after birth | Parental knowledge of home skincare was assessed using questionnaire scores on skin management knowledge |
Countries
China
Outcome results
None listed