Shenzhen Neonatal Stroke Registry: Protocol for a 300-Patient Cohort Study

300 neonates diagnosed with stroke will be enrolled from 22 hospitals in Shenzhen, China, between January 2025 and December 2030. This multicenter, prospective cohort study protocol details the establishment of an online registry to track incidence, risk factors, and neurodevelopmental outcomes up to age five. The study integrates placental pathology and a biobank of stool and breast milk samples to explore the metabolic-inflammatory nexus of neonatal injury.

Use Cases

• Predicting motor outcomes based on integrated prognostic frameworks including MRI, GMA, and HINE assessments.
• Characterizing clinical subtypes of neonatal stroke, including arterial ischemic, hemorrhagic, and cerebral venous sinus thrombosis.
• Identifying prenatal and perinatal risk factors for neonatal stroke from standardized electronic case report forms.
• Developing and validating a prognostic prediction model for long-term neurodevelopmental outcomes.
• Analyzing the relationship between placental pathology and neonatal stroke outcomes.

Strengths

• Protocol outlines a planned enrollment of 300 patients from 22 hospitals, providing a substantial cohort.
• Longitudinal follow-up is planned until age five, enabling long-term outcome assessment.
• Data collection integrates multiple standardized assessment tools, including Bayley Scales, 3T cranial MRI, and video-EEG.

Limitations

• The dataset is a 213.1 KB protocol document (DOCX), not the actual registry data, which limits immediate analysis.
• Column-level documentation is absent; field semantics must be inferred from the protocol description.
• Row count for the eventual registry data is unknown, which may limit suitability assessment.

Provenance

Source

Protocol authored by Xiaoli Zhao and posted on figshare.

Collection Method

Data will be collected via standardized electronic case report forms (eCRFs) from a network of hospitals.

Time Range

Study enrollment planned from January 2025 to December 2030.

Freshness

Last updated 2026-05-08 09:41:04; freshness should be verified.

Geography

Shenzhen, China.