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

NCT ID: NCT06544096

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

692 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-01-15

Brief Summary

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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

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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

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Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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the control group

Routine health education

Group Type ACTIVE_COMPARATOR

control group (routine health education)

Intervention Type 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.

Using"WeChat platform+health care" group

Use"WeChat platform+health care"

Group Type EXPERIMENTAL

intervention group (WeChat platform + healthcare)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hu Xiaojing, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

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Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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2024/6/7

Identifier Type: -

Identifier Source: org_study_id

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