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DNA of pathogens in neonates suspected for sepsis

Next generation sequencing of pathogens in neonates suspected for sepsis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28270
Enrollment
20
Registered
2018-07-26
Start date
2018-09-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Neonatal sepsis Neonatale infectie

Interventions

A blood culture is the golden standard to diagnose sepsis and will be obtained when a child is clinically suspected for sepsis. Additional to the blood culture, 0.5 ml blood is obtained for the study.

Sponsors

MMC Veldhoven
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet both of the following criteria: - Clinical sepsis according to criteria according to Oxford Vermont Neonatal Network: Apnea, progressive respiratory distress, hemodynamic instability, temperature instability, and/or feeding intolerance - Blood culture obtained - Gestational age above 26 weeks - Birth weight above 800 grams For the control group, neonates must be free of symptoms correlated to infection. Control patients will be matched for age. Furthermore, A clinical indication to draw a blood sample must be present as an infant will not be punctured for the study.

Exclusion criteria

Exclusion criteria: - Antibiotic therapy within 72 hours before blood sampling - Congenital abnormalities - Genetic disorders - Suspected syndromes - Immunological disorders

Design outcomes

Primary

MeasureTime frame
Identification of pathogens in neonates suspected for sepsis with next generation sequencing.

Contacts

Public ContactS.B.E.A. Hoeks

Máxima Medisch Centrum

sanne.hoeks@mmc.nl040 8889350

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)