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Optimization of Blood Sampling Decisions and Pathogen Characteristics in Non-Severe Late-Onset Sepsis in Preterm Neonates

Clinical and Pathogen Analysis in Preterm Neonatal Sepsis - CPAPNS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114127
Enrollment
Unknown
Registered
2025-12-08
Start date
2025-12-08
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

late-onset sepsis in preterm infants

Interventions

Immediate blood sampling group:none
Delayed observation group:none

Sponsors

Anhui Medical University First Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Post-menstrual age > 72 h; 2. At least one non-critical clinical finding as defined in the 2025 Expert Consensus on Neonatal Sepsis for Primary-Care Institutions; 3. Signed informed consent from the legal guardian.

Exclusion criteria

Exclusion criteria: Exclusion Criteria (any one disqualifies) 1. Critical illness mandating immediate resuscitation: a. Apnea requiring invasive ventilation; b. Shock requiring cardiopulmonary resuscitation or vasoactive drugs; c. Clinical seizures. 2. Established major risk factors for late-onset sepsis: a. Current central venous access (e.g., PICC, UVC); b. Ongoing invasive mechanical ventilation; c. Surgery within the preceding 7 days. Antibiotic status: 3. a. No active infection but receiving targeted antibiotic prophylaxis; b. Active infection under therapeutic antibiotic treatment. 4. Severe congenital malformation(s) or decision to withhold/withdraw care.

Design outcomes

Primary

MeasureTime frame
7-day missed diagnosis rate of LOS in delayed blood sampling group;

Secondary

MeasureTime frame
Type of blood sampling decision (immediate/delayed);Final diagnosis of late-onset sepsis (LOS);Dynamic change score of non-critical symptoms;Pathogen distribution of LOS;Pathogen drug resistance spectrum;Antibiotic usage rate (immediate vs delayed group);

Countries

China

Contacts

Public ContactWang Yang

Anhui Medical University First Affiliated Hospital

wangyang@ahmu.edu.cn+86 139 5695 6826

Outcome results

None listed

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