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PISA

Procalcitonin in Saliva as a Potential Non-Invasive Biomarker in the Evaluation of Infection Risk in Neonates - PISA

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57954
Enrollment
54
Registered
2025-03-18
Start date
2026-03-05
Completion date
Unknown
Last updated
2026-05-18

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

Conditions

Early Onset Neonatal Sepsis Bacterial Infection in Newborn

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Procalcitonin serum measurement in routine care as part of early onset sepsis risk assesment 

Exclusion criteria

Exclusion criteria: Severe vomiting Oral defects interfering with saliva collection 

Design outcomes

Primary

MeasureTime frame
Correlation between saliva procalcitonin and serum procalcitonin 

Secondary

MeasureTime frame
- Correlation between saliva procalcitonin level and infection (positive culture, neonatal sequential organ failure assessment score, level of respiratory support) - Intraclass correlation coefficient between saliva C-reactive protein and serum C-reactive protein 

Countries

Netherlands

Contacts

Public ContactT.B. Robles

Erasmus MC, Universitair Medisch Centrum Rotterdam

t.robles@erasmusmc.nl+31 10 704 0704

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 22, 2026