InfantsNCT06544096
Application Evaluation of Newborn Home Skin Care Management System Under the Service of "WeChat Platform+Health Care"
A study testing intervention group (WeChat platform + healthcare) in people with Infants, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Infants
- What is being tested?
- intervention group (WeChat platform + healthcare)
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 692 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Evaluation of the Effectiveness of a Neonatal Home Skin Care Guidance Based on We-chat: A Cluster-Randomized Controlled Trial
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.
Read the 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
- Being tested
- intervention group (WeChat platform + healthcare), control group (routine health education)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention group (WeChat platform + healthcare)Behavioural
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.
control group (routine health education)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| the control group | Active comparator | Routine health education Receives: Behavioral: control group (routine health education) |
| Using"WeChat platform+health care" group | Experimental | Use"WeChat platform+health care" Receives: Behavioral: intervention group (WeChat platform + healthcare) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within two months after birth
Secondary outcomes (3)
Incidence rate of neonatal home atopic dermatitis (AD)
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.
Measured: Within two months after birth
Rate of Hospital Visits for Skin Problems
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.
Measured: Within two months after birth
Parental Knowledge of Home Skincare
Parental knowledge of home skincare was assessed using questionnaire scores on skin management knowledge
Measured: Within two months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Aug 2024
- Primary completion30 Sep 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfantsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 692 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hu Xiaojing, PhD, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544096
- Sponsor's protocol ID
- 2024/6/7
- Status last verified
- Apr 2025
- First submitted
- 29 Jul 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41174684
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Neonatal Home Skin Care Guidance Based on We-chat: A Cluster-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06544096
- Acronym / sponsor ID
- 2024/6/7
- Conditions
- Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 692 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the control group | Active comparator | Behavioral: control group (routine health education)Routine health education |
| Using"WeChat platform+health care" group | Experimental | Behavioral: intervention group (WeChat platform + healthcare)Use"WeChat platform+health care" |
Who may qualify
- Ages
- 1 day to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Using"WeChat platform+health care" group |
| 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. | Behavioural | the control group |
Primary outcome
Incidence of diaper dermatitis in newborns at home
Time frame: 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.
3 secondary outcomes
Incidence rate of neonatal home atopic dermatitis (AD)
Time frame: Within two months after birth
Rate of Hospital Visits for Skin Problems
Time frame: Within two months after birth
Parental Knowledge of Home Skincare
Time frame: Within two months after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Derived from this study: PubMed 41174684Yang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hu Xiaojing, PhD principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention group (WeChat platform + healthcare) in people with Infants, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of diaper dermatitis in newborns at home (time frame: Within two months after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06544096, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.