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The value of umbilical venous blood routine, PCT and CRP in predicting early-onset sepsis of neonates with high risk factors of infection

The value of umbilical cord blood PCT and CRP in the diagnosis of early-onset sepsis in newborns with high risk factors of infection

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000039751
Enrollment
Unknown
Registered
2020-11-08
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-02-16

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

Conditions

early-onset sepsis in newborns

Interventions

Gold Standard:According to the expert consensus on the diagnosis and treatment of neonatal sepsis (2019 edition), neonatal early infection refers to the infection occurring within 72 hours after birth
Index test:PCT, CRP, NLR

Sponsors

Yiwu Maternity and Children Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Newborns who delivered in our hospital from December 2020 to December 2021, whose mothers have no major internal or surgical diseases and have high risk factors for infection. Risk factors of infection refer to those who meet any of the following conditions: (1) Premature rupture of membranes with > for 18h; (2) Maternal fever in the third trimester of pregnancy or increased blood PCT, CRP and WBC; (3) The amniotic fluid III pollution or odor; (4) Chorioamnionitis; (5) Positive vaginal GBS culture at 34 weeks of pregnancy; (6) History of fetal distress or neonatal asphyxia; (7) Placental abruption; (8) Gestational age less than 33 weeks.

Exclusion criteria

Exclusion criteria: Severe congenital malformation, genetic metabolic diseases, chromosomal diseases, and failure to complete the study procedures for various reasons.

Design outcomes

Primary

MeasureTime frame
early-onset sepsis;blood culture;blood routine;Clinical symptoms of infection;SEN, SPE, ACC, AUC of ROC, PPV, NPV;

Countries

China

Contacts

Public ContactShujun Chen

Yiwu Maternity and Children Hospital

cce1377@163.com+86 13575939201

Outcome results

None listed

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