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

Last updated: July 15, 2020
Sponsor: Clinical Research Centre, Malaysia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Crohn's Disease

Soft Tissue Infections

Treatment

N/A

Clinical Study ID

NCT03578978
NMRR-17-2491-38373
  • Ages < 30
  • All Genders

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.

Eligibility Criteria

Inclusion

Neonates with suspected LONS/NEC Inclusion Criteria:

  • Infants with signs and symptoms suggestive of sepsis and/or NEC and requiring fullsepsis screening and start of intravenous antibiotic(s), or a change of antibiotics (if already on)

  • Infants with postnatal age greater than 72 hours and less than 28 days of life, of allgestation

  • Parents of potential neonates who are willing to give written informed consent Healthy subjects Inclusion Criteria:

  • Clinically well infants admitted to Sibu Hospital for reasons other than neonatalsepsis or NEC

  • Infants with postnatal age greater than 72 hours and less than 28 days of life, of allgestation

Exclusion

Exclusion Criteria:

  • Infants who have lethal or life-threatening congenital abnormalities

  • Infants who have chromosomal abnormalities

  • Infants who have hypoxic ischemic encephalopathy

  • Infants who are on steroid treatment

  • Infants who received blood transfusions

  • Post-operative infants

Study Design

Total Participants: 200
Study Start date:
July 01, 2018
Estimated Completion Date:
August 31, 2021

Study Description

The diagnosis of neonatal sepsis is challenging especially the very low birth weight infants as the signs and symptoms of sepsis are nonspecific and can be attributed to non-infected aetiologies including exacerbation of bronchopulmonary dysplasia, apnoea of prematurity and gastroesophageal reflux. Blood culture remains the gold standard for diagnosing septicaemia (either bacteremia or fungemia). However, its effectiveness in the population of preterm infants is compromised.Given the dire consequences of not treating the sepsis early, clinicians tend to have a low threshold for treatment. This leads to overuse of antimicrobials, promotion of antimicrobial resistance, exposure of infants to avoidable side effects from the antimicrobial treatment, prolonged hospitalisation and increased healthcare costs. Hence, there is a need for a clearly defined algorithm for diagnosing LONS and NEC. This study aims to examine the diagnostic utilities of a panel of sepsis biomarkers and explore if they can be incorporated into a diagnostic algorithm which hopefully, can be translated into clinical practice in the future.

Connect with a study center

  • Sarawak General Hospital

    Kuching, Sarawak 93586
    Malaysia

    Active - Recruiting

  • Sibu Hospital

    Sibu, Sarawak 96000
    Malaysia

    Active - Recruiting

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