Necrotizing Enterocolitis, Neonatal SEPSIS
Conditions
Brief 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.
Detailed 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.
Interventions
OTHERNo intervention
No intervention will be given to study subjects. Only blood will be obtained from study subjects.
Sponsors
Clinical Research Centre, Malaysia
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
72 Hours to 30 Days
Healthy volunteers
No
Inclusion criteria
Neonates with suspected LONS/NEC Inclusion Criteria: * Infants with signs and symptoms suggestive of sepsis and/or NEC and requiring full sepsis 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 all gestation * 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 neonatal sepsis or NEC * Infants with postnatal age greater than 72 hours and less than 28 days of life, of all gestation
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic utilities of biomarkers of interest in diagnosing LONS | Hour 0 to 72 | Diagnostic utilities of each individual biomarker (procalcitonin, interleukin-6, serum amyloid A and apolipoprotein C2) or in combination in diagnosing LONS |
| Diagnostic utilities of biomarkers of interest in diagnosing NEC | Hour 0 to 72 | Diagnostic utilities of each individual biomarker (procalcitonin, interleukin-6, serum amyloid A and apolipoprotein C2) or in combination in diagnosing LONS |
Countries
Malaysia
Contacts
Primary ContactShirin Hui Tan
Outcome results
None listed