NCT06544096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
692

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

July 29, 2024

Last Update Submit

April 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of diaper dermatitis in newborns at home

    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.

    Within two months after birth

Secondary Outcomes (3)

  • Incidence rate of neonatal home atopic dermatitis (AD)

    Within two months after birth

  • Rate of Hospital Visits for Skin Problems

    Within two months after birth

  • Parental Knowledge of Home Skincare

    Within two months after birth

Study Arms (2)

the control group

ACTIVE COMPARATOR

Routine health education

Behavioral: control group (routine health education)

Using"WeChat platform+health care" group

EXPERIMENTAL

Use"WeChat platform+health care"

Behavioral: intervention group (WeChat platform + healthcare)

Interventions

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.

Using"WeChat platform+health care" group

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.

the control group

Eligibility Criteria

Age1 Day - 2 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (1)

  • Yang T, Chen Y, Dou Y, Qiu M, Wang Y, Jiang S, Hu X. Parent-guided home skin care for infants via a WeChat platform: a study protocol for a cluster randomized controlled trial. Trials. 2025 Oct 31;26(1):458. doi: 10.1186/s13063-025-09186-x.

MeSH Terms

Interventions

Delivery of Health CareControl Groups

Intervention Hierarchy (Ancestors)

Patient Care ManagementHealth Services AdministrationHealth Care Quality, Access, and EvaluationEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Hu Xiaojing, PhD

    Children's Hospital of Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2024

First Posted

August 9, 2024

Study Start

August 1, 2024

Primary Completion

September 30, 2024

Study Completion

January 15, 2025

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations