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

NCT03578978 | Unknown

• 1 other identifier: NMRR-17-2491-38373
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Neonatal SEPSIS; Necrotizing Enterocolitis

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Hour 0 to 72

Study Arms (2)

Neonates with suspected LONS and/or NEC

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

Healthy neonates

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

Interventions

No intervention OTHER

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

Healthy neonates; Neonates with suspected LONS and/or NEC

Eligibility Criteria

• Age: 72 Hours - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Research Centre, Malaysia: lead

Study Sites (2)

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

RECRUITING

Sibu Hospital

Sibu, Sarawak, 96000, Malaysia

RECRUITING

MeSH Terms

Conditions

Neonatal Sepsis; Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Shirin Hui Tan

  Clinical Research Centre, Sarawak General Hospital, Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shirin Hui Tan

CONTACT

+6082-276820; shirin_hui88@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 6, 2018
• Study Start: July 1, 2018
• Primary Completion: May 31, 2021
• Study Completion: August 31, 2021
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)