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Clinical Application Value of Heparin-Binding Protein Levels in Predicting Early-Onset Neonatal Sepsis and Prognosis: A Single-Center Prospective Cohort Study

Clinical Application Value of Heparin-Binding Protein Levels in Predicting Early-Onset Neonatal Sepsis and Prognosis: A Single-Center Prospective Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300073867
Enrollment
Unknown
Registered
2023-07-24
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-07-30

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

Conditions

early onset sepsis

Interventions

Gold Standard:The diagnostic criteria for early-onset sepsis (EOS) include meeting one or more of the following criteria: 1) Premature rupture of membranes (=18 hours) with positive culture confirming
2) Clinical symptoms including respiratory distress (retractions or apnea), tachycardia (heart rate > 160 bpm), bradycardia (heart rate 3s), neurological impairment (seizures, irritability, or lethar
3) Positive blood or cerebrospinal fluid culture, and two or more positive results from routine laboratory tests (WBC 25×10^9/L, CRP > 5 mg/L, immature neutrophil to total neutrophil ratio (I/T ratio
Index test:HBP, blood routine, hypersensitive CRP, PCT, blood culture

Sponsors

Wenling Maternal and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Experimental group: High-risk newborns delivered in our hospital, including preterm infants, infants requiring resuscitation at birth, infants born to mothers with chorioamnionitis (CAM) or maternal fever during labor, infants with Group B Streptococcus (GBS) colonization or bacteriuria, infants with a history of GBS infection, infants with premature rupture of membranes (PROM) lasting =18 hours, infants with contaminated amniotic fluid, and infants presenting symptoms suggestive of bacterial infection, such as respiratory distress, seizures, hypotension, poor feeding tolerance, decreased intake, vomiting, reduced movement, delayed jaundice regression, body temperature maintained below 35°C or fever (body temperature > 37.5°C). Control group: Healthy volunteers.

Exclusion criteria

Exclusion criteria: Experimental group:High-risk newborns whose families refuse hospitalization, and newborns with congenital malformations and other severe life-threatening conditions, including congenital heart disease, metabolic disorders, chromosomal abnormalities, etc. Control group:newborns with congenital malformations and other severe life-threatening conditions, including congenital heart disease, metabolic disorders, chromosomal abnormalities, etc.

Design outcomes

Primary

MeasureTime frame
HBP;PCT;CPR;ROC curve;Sensitivity;specificity;

Countries

China

Contacts

Public ContactXiyang Chen

Wenling Maternal and Child Health Care Hospital

11918403@zju.edu.cn+86 576 8616 8039

Outcome results

None listed

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