Skip to content

Study on the application effect of a follow-up system for mild head injury in children: A prospective randomized controlled study

Study on the application effect of a follow-up system for mild head injury in children

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088407
Enrollment
Unknown
Registered
2024-08-19
Start date
2024-08-27
Completion date
Unknown
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

head injury

Interventions

Assisted group:The doctor completes routine education on head injury related precautions education, and the head injury follow-up system is provided for parents and guardians of affected children to u
Control group:The doctor completes routine education on head injury related precautions education.

Sponsors

Guangzhou Medical University Affiliated Women and Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 17 Years

Inclusion criteria

Inclusion criteria: (1) Age: 0-17 years old, gender not limited. (2) The doctor assessed the head injury as low-risk according to the PECARN head injury rules. (3) Head trauma occurred within 24 hours of inclusion in the study. (4) At least one guardian must be able to use a smartphone and agree to participate in the study. (5) The guardian signs the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Medical history: Children with a history of severe neurological disorders or traumatic brain injury. (2) Comorbidities: When a head injury occurs, it is accompanied by other serious bodily injuries that require urgent medical treatment. (3) Cognitive impairment: The child has severe cognitive impairment and cannot undergo effective follow-up. (4) Compliance: The guardian stated that they are unable to record follow-up as required or are unwilling to accept randomization. (5) No smartphones: There are no available smartphones in the home or guardians will not use the relevant software. (6) Not followed up within the specified time frame. (7) Incomplete collection of clinical data. (8) Have participated in other clinical studies or during the follow-up period of other clinical studies during the visit.

Design outcomes

Primary

MeasureTime frame
CT examination ratio;Return rate of pediatric patients to the hospital for treatment;Incidence of complications from head injury;

Secondary

MeasureTime frame
Compliance of parents or guardians;Anxiety level of parents or guardians;Satisfaction with diagnosis and treatment;Health economics indicators;

Countries

China

Contacts

Public ContactTianxin Zhao

Guangzhou Medical University Affiliated Women and Children's Medical Center

txzhaos@163.com+86 133 5281 0910

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026