Diagnostic value of soluble CD14 subtype in neonatal sepsis

Diagnostic value of soluble CD14 subtype in neonatal sepsis - Diagnostic value of soluble CD14 subtype in neonatal sepsis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55522

Enrollment

200

Registered

2018-01-23

Start date

2018-07-30

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

bacterial infection neonatal sepsis

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: • Admitted to the Neonatal unit • Undergoing sepsis evaluation according to the Dutch early onset neonatal sepsis guideline, or local late-onset sepsis guideline. • Informed consent of parents or legal guardian(s)

Exclusion criteria

Exclusion criteria: • Confirmed intrauterine infection (toxoplasmosis, rubella, cytomegalovirus, syphilis and herpes)

Design outcomes

Primary

Measure	Time frame
The main study parameter is the difference in plasma sCD14-ST level between infants with and without neonatal sepsis.	—

Secondary

Measure	Time frame
- the difference in plasma sCD14-ST level over time between infants with and without neonatal sepsis. - discordance in positive and negative outcomes of molecular blood culturing (IS-pro) compared to outcomes of whole blood culturing between infants with and without neonatal sepsis - difference in intestinal microbiota composition between infants who received antibiotics less than 72 hours compared to infants who received antibiotics longer than 72 hours.	—

Measure

Time frame

- the difference in plasma sCD14-ST level over time between infants with and without neonatal sepsis. - discordance in positive and negative outcomes of molecular blood culturing (IS-pro) compared to outcomes of whole blood culturing between infants with and without neonatal sepsis - difference in intestinal microbiota composition between infants who received antibiotics less than 72 hours compared to infants who received antibiotics longer than 72 hours.

—

Countries

Netherlands

Outcome results