Diagnostic value of soluble CD14 subtype in neonatal sepsis

Completed

• Conditions: bacterial infection; neonatal sepsis; 10004018; 10028920

• Registration Number: NL-OMON55522
• Lead Sponsor: OLVG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

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

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the difference in plasma sCD14-ST level between<br /><br>infants with and without neonatal sepsis. </p><br>

Secondary Outcome Measures

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