Next generation sequencing of pathogens in neonates suspected for sepsis

Next generation sequencing of pathogens in neonates suspected for sepsis - NGS neonates pilot

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48675

Enrollment

Registered

2018-10-30

Start date

2019-04-03

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Infection Sepsis

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: - Clinical sepsis according to criteria according to Vermont Oxford Neonatal Network: Apnea, temperature instability, feeding intolerance, worsening respiratory distress or hemodynamic instability. - Blood culture obtained - Gestational age above 26 weeks - Birth weight above 800 gram For the control group, neonates must be free of infection. Furthermore, a clinical indication for a blood sample must be present. This group will be matched with the cases for AD.

Exclusion criteria

Exclusion criteria: - Gestational age below 26 weeks - Birth weight below 800 grams - Antibiotic therapy within 72 hours before blood sampling - Congenital abnormalities - Genetic disorders - Suspected syndromes - Immunological disorders

Design outcomes

Primary

Measure	Time frame
This observational pilot study investigates proof of concept of a well-known technique combined with analysis by bioinformatics, in a new clinical setting. The primary study parameter is the identification of pathogens with NGS in neonates suspected for sepsis. Normalized read counts of classified, non-human reads for each plasma sample are calculated, resulting in a quantification of distinct species. To evaluate the significance of read abundances for all species classified, normalized read counts are compared for each species between all septic patients and controls. To support discrimination by relevance, we will combine abundance and unlikeliness of observed read counts for each species found in a sample. Species which are significantly represented in a sample with a p value	—

Measure

Time frame

This observational pilot study investigates proof of concept of a well-known technique combined with analysis by bioinformatics, in a new clinical setting. The primary study parameter is the identification of pathogens with NGS in neonates suspected for sepsis. Normalized read counts of classified, non-human reads for each plasma sample are calculated, resulting in a quantification of distinct species. To evaluate the significance of read abundances for all species classified, normalized read counts are compared for each species between all septic patients and controls. To support discrimination by relevance, we will combine abundance and unlikeliness of observed read counts for each species found in a sample. Species which are significantly represented in a sample with a p value

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Countries

Netherlands

Outcome results