An observational study in Neonatal SEPSIS and Necrotizing Enterocolitis, sponsored by Clinical Research Centre, Malaysia. Status unknown at 2 sites in Malaysia. Open to participants aged 72 Hours to 30 Days. Per ClinicalTrials.gov, last updated 2020-07-17.
Sponsored by Clinical Research Centre, Malaysia · Observational
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.
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's planned enrollment of 200 is above the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →Clinical Research Centre, Malaysia is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
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Neonates suspected of LONS and/or NEC admitted to the Neonatal Intensive Care Unit (NICU), Special Care Nursery (SCN) or Paediatric Medical 27 (PM27) wards in Sibu Hospital, Malaysia during the period of 1 July 2018 and 31 May 2020 will be screened for their eligibility. Apart from that, neonates admitted to Sibu Hospital for reasons other than neonatal sepsis or NEC will also be recruited into the study during the period of 1 June 2018 and 31 May 2020.
Neonates with suspected LONS/NEC
Inclusion Criteria:
Healthy subjects
Inclusion Criteria:
Exclusion Criteria:
A group of 150 neonates with suspected LONS and/or NEC will be recruited. No intervention will be given to the subjects. Blood sampling will be obtained from subjects at 4 time points (Hour 0, 24, 48 and 72) for analysis of the sepsis biomarkers of interest.
Other: No intervention
A group of 50 neonates who are clinically well, admitted to the NICU for reasons other than neonatal sepsis or NEC will be recruited into the study to explore the kinetics and concentrations of the panel of biomarkers in healthy subjects comparing to subjects with suspected LONS/NEC. No intervention will be given to the subjects. Blood sampling will be obtained from subjects at 4 time points (Hour 0, 24, 48 and 72) for analysis of the sepsis biomarkers of interest.
Other: No intervention
No intervention will be given to study subjects. Only blood will be obtained from study subjects.
Diagnostic utilities of biomarkers of interest in diagnosing LONS
Diagnostic utilities of each individual biomarker (procalcitonin, interleukin-6, serum amyloid A and apolipoprotein C2) or in combination in diagnosing LONS
Time frame: Hour 0 to 72
Diagnostic utilities of biomarkers of interest in diagnosing NEC
Diagnostic utilities of each individual biomarker (procalcitonin, interleukin-6, serum amyloid A and apolipoprotein C2) or in combination in diagnosing LONS
Time frame: Hour 0 to 72
Plan to share: No
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This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Clinical Research Centre, Malaysia