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Dynamic Changes of Inflammatory Markers and Optimization of Clinical Decision-Making in Neonates with Suspected Sepsis in a Level II, Grade A Neonatal Unit

Dynamic Changes of Inflammatory Markers and Optimization of Clinical Decision-Making in Neonates with Suspected Sepsis in a Level II, Grade A Neonatal Unit

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600120978
Enrollment
Unknown
Registered
2026-03-24
Start date
2026-03-31
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Neonatal sepsis

Interventions

Clinically Confirmed Infection Group:None
Antibiotic Response Group:None
Initial Treatment Failure Group:None

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Admitted to the hospital with a diagnosis of "suspected neonatal sepsis." 2. Met the "suspected diagnosis" criteria according to the "Expert Consensus on the Diagnosis and Management of Neonatal Sepsis (2024 Edition)." 3. Completed screening for inflammatory markers (CRP or routine blood parameters) upon admission. 4. Gestational age > 32 weeks and birth weight >= 1500 grams.

Exclusion criteria

Exclusion criteria: 1. Severe congenital anomalies or genetic metabolic diseases. 2. Major perinatal injuries. 3. Extremely incomplete clinical data. 4. Withdrawal of treatment, transfer to another hospital, or death during hospitalization.

Design outcomes

Primary

MeasureTime frame
Predictive efficacy of antibiotic decision nodes (AUC value);Differentiation of low-risk infection prediction models (C-index);

Secondary

MeasureTime frame
Inflammatory characteristics;

Countries

China

Contacts

Public ContactLei Lei

Shanghai Changhai Hospital

doctorlei_lei@163.com+86 139 1607 2205

Outcome results

None listed

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