Clinical study on the diagnostic value of plasma presepsin in neonatal early onset sepsis

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2300072525

Enrollment

Unknown

Registered

2023-06-15

Start date

2023-07-01

Completion date

Unknown

Last updated

2023-06-18

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

Conditions

Neonatal Sepsis

Interventions

Newborns with high risk factors for early onset sepsis:None

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Newborns delivered in the Department of Obstetrics, Peking University Shenzhen Hospital from January 1,2023 to December 31,2026 meet two of the following four criterion: 1) the mother's premature rupture of membranes =24 hours; 2) The mother has fever in the 24 hours before delivery, and the temperature is > 38?; 3) The increase of blood WBC within 24 hours before and after delivery was =15×109/L, accompanied by an increase of CRP =10mg/L; 4) Uterine tenderness or smelly amniotic fluid.

Exclusion criteria

Exclusion criteria: Newborns meet any of the following: 1) death or abandonment of treatment within 24 hours of birth; 2) Patients with severe congenital malformations and indications for surgery; 3) The guardian does not sign the informed consent.

Design outcomes

Primary

Measure	Time frame
Presepsin;	—

Countries

China

Contacts

Public ContactHu Xiaoyan

Peking University Shenzhen Hospital

xyhu77@126.com+86 139 2466 6390

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 17, 2026