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Diagnostic Performance and Clinical Impact of Cerebrospinal Fluid Metagenomic Next-Generation Sequencing in Neonatal Intracranial Infections

Diagnostic Performance and Impact of Cerebrospinal Fluid Metagenomic Next-Generation Sequencing in Neonatal Intracranial Infections

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128310
Enrollment
Unknown
Registered
2026-07-17
Start date
2026-05-26
Completion date
Unknown
Last updated
2026-07-20

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

Conditions

Neonatal Intracranial Infections

Interventions

Observational group:None

Sponsors

Children's Hospital,Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1. Admission age =2 of the non-specific hematological infection markers (white blood cell count, platelet count, C-reactive protein, procalcitonin); (2) Presence of any neurological abnormality (symptoms or signs), including: poor mental responsiveness or irritability, or seizures/convulsions or fixed gaze, or bulging fontanelle or nuchal rigidity, or abnormal muscle tone. 3. Cerebrospinal fluid (CSF) samples are sent out for metagenomic next-generation sequencing (mNGS).

Exclusion criteria

Exclusion criteria: 1. Discharge against medical advice; 2. Missing data.

Design outcomes

Primary

MeasureTime frame
Clinical impact;—

Secondary

MeasureTime frame
The sensitivity of mNGS for pathogen detection;—

Countries

China

Contacts

Public ContactDu Lizhong

Children's Hospital,Zhejiang University School of Medicine

dulizhong@zju.edu.cn+86 571 87068247

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026