Application of monitoring inflammatory factors dynamically in suspected neonatal early-onset sepsis

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200062934

Enrollment

Unknown

Registered

2022-08-24

Start date

2022-08-24

Completion date

Unknown

Last updated

2023-04-12

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

Conditions

Neonatal early-onset sepsis

Interventions

Intervention group:PCT (normal twice every 24 hours) guided the application of antibiotic course

Conrol group:Empiric antibiotic therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Analysis on the value of umbilical cord blood inflammation index in neonatal sepsis: newborns delivered in obstetrics department of our hospital from August 2022 to may 2023 Inclusion criteria of PCT guided antibiotic treatment: newborns with admission age = 35 weeks and suspected EOS, infection risk assessment <= 2 points and requiring antibiotic treatment; The diagnostic criteria of EOS refer to the expert consensus on diagnosis and treatment of neonatal sepsis (2019 version) Bedside detection of inflammatory factors included: children who need to collect inflammatory indicators (PCT, CRP, IL-6, SAA) due to their own conditions

Exclusion criteria

Exclusion criteria: Exclusion criteria for the value analysis of cord blood inflammatory indicators in neonatal sepsis: there are clear indications for antibiotic treatment or prevention other than EOS (for example, congenital diseases or congenital abnormalities with infection risk, surgical indications, genetic and metabolic diseases, severe asphyxia, children with HIV infection or other immune defects), positive blood culture results collected at admission The infection risk score at admission was 3 Exclusion criteria of PCT guided antibiotic treatment: severe asphyxia, various congenital malformations, congenital heart disease and genetic metabolic diseases Exclusion criteria for bedside detection of inflammatory factors: samples with inconsistent blood collection time due to venous blood hemolysis or peripheral blood coagulation, and those without corresponding control blood samples from either route.

Design outcomes

Primary

Measure	Time frame
levels of inflammatory factors;	—

Countries

China

Contacts

Public ContactShi Wen Jing

horse20021019@163.com13917621217

Outcome results

None listed

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