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A Panel of Biomarkers in Diagnosing Late-onset Neonatal Sepsis and Necrotizing Enterocolitis in Sibu Hospital

NCT03578978 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2020-07-17

No results posted yet for this study

Summary

This is a cross-sectional study to evaluate the utilities of a panel of biomarkers (Procalcitonin, Interleukin-6, Serum Amyloid A and Apolipoprotein C2) versus the gold standard blood culture result diagnosing late-onset neonatal sepsis (LONS) and/or necrotizing enterocolitis (NEC). Neonates who meet the initial screening criteria for suspected LONS or NEC will be recruited into the study. A group of 50 neonates who are clinically well, admitted to the nursery or general ward for reasons other than neonatal sepsis or NEC will also be recruited into the study.

Conditions

  • Neonatal SEPSIS
  • Necrotizing Enterocolitis

Interventions

OTHER

No intervention

No intervention will be given to study subjects. Only blood will be obtained from study subjects.

Sponsors & Collaborators

  • Clinical Research Centre, Malaysia

    lead OTHER

Principal Investigators

  • Shirin Hui Tan · Clinical Research Centre, Sarawak General Hospital, Malaysia

Eligibility

Min Age
72 Hours
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2021-05-31
Completion
2021-08-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03578978 on ClinicalTrials.gov