Skip to content

Prospective observational study on the application of non-contact monitor in the monitoring of children with central nervous system infection

Prospective observational study on the application of non-contact monitor in the monitoring of children with central nervous system infection

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500110381
Enrollment
Unknown
Registered
2025-10-13
Start date
2024-05-25
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Infectious diseases of the central nervous system in children

Interventions

Gold Standard:The monitoring indicators of traditional ECG monitors in the same period are taken as the gold standard.
Index test:Non-contact monitor

Sponsors

Beijing Children’s Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 4 Years

Inclusion criteria

Inclusion criteria: 1. Age: 29 days to 4 years after birth; 2. All selected children meet the modified case classification criteria for bacterial meningitis surveillance from the World Health Organization (WHO) or criteria for suspected encephalitis; WHO modified bacterial meningitis surveillance case classification criteria: (1) Age from 28 days to 4 years; (2) Acute onset; (3) Fever (axillary temperature >=38°C) and/or the following clinical manifestations: headache, altered consciousness, refusal to feed, vomiting, irritability, drowsiness, hypotonia, seizures, bulging or swollen anterior fontanelle, at least one clinical symptom or sign of meningitis; (4) One of the following two situations: cerebrospinal fluid (CSF) routine WBC >100 cells/ml; or CSF routine WBC 10-100 cells/ml and one of the following: altered appearance of the CSF or glucose 100 mg/dl; Suspected encephalitis criteria: (1) Acute fever; (2) Meeting one of the following: headache, vomiting, seizures, altered consciousness; (3) Lumbar puncture cell count >=15 cells/ml.

Exclusion criteria

Exclusion criteria: 1. Cases of autoimmune encephalitis; 2. Cases of central nervous system involvement in neoplastic diseases; 3. Cases with hemorrhagic cerebrospinal fluid during lumbar puncture; 4. Children with cerebrospinal fluid volume less than 1ml; 5. Children who refuse to participate for various reasons.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;Accuracy;

Secondary

MeasureTime frame
Heart rate;Respiratory rate;Oxygen saturation;Blood pressure;

Countries

China

Contacts

Public ContactLingyun Guo

Beijing Children’s Hospital, Capital Medical University

guolybj@163.com+86 136 9123 4569

Outcome results

None listed

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