Neonatal SEPSISPISALONSNCT03578978
A Panel of Biomarkers in Diagnosing Late-onset Neonatal Sepsis and Necrotizing Enterocolitis in Sibu Hospital
An observational study of Neonatal SEPSIS and Necrotizing Enterocolitis, run by Clinical Research Centre, Malaysia at 2 sites in Malaysia.
Trial 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). Read more about this study
- Who is it for?
- Ages 72 hours to 30 days
- Conditions the study is for
- Neonatal SEPSIS, Necrotizing Enterocolitis
- How many people
- 200 participants
- Where
- 2 sitesMalaysia
- Study dates
- 1 Jul 2018to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 72 hours to 30 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Malaysia2 sites, 2 recruiting
- Recruiting
Sarawak General Hospital
Kuching, Sarawak, 93586
Shirin H Tan, 6082276820, shirin_hui88@yahoo.com
Ann Cheng Wong
- Recruiting
Sibu Hospital
Sibu, Sarawak, 96000
Shirin Hui Tan
See Chang Wong
About this study
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.
Read the 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.
- Conditions
- Neonatal SEPSIS, Necrotizing Enterocolitis
- Being tested
- No intervention
- Medical subject headings
- Neonatal Sepsis, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention will be given to study subjects. Only blood will be obtained from study subjects.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Hour 0 to 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start1 Jul 2018
- Primary completion31 May 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal SEPSISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Research Centre, Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shirin Hui Tan, Principal investigator, Clinical Research Centre, Sarawak General Hospital, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578978
- Sponsor's protocol ID
- NMRR-17-2491-38373
- Acronym
- PISALONS
- Status last verified
- Jul 2020
- First submitted
- 25 Jun 2018
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Panel of Biomarkers in Diagnosing Late-onset Neonatal Sepsis and Necrotizing Enterocolitis in Sibu Hospital
- ClinicalTrials.gov ID
- NCT03578978
- Acronym / sponsor ID
- PISALONS / NMRR-17-2491-38373
- Conditions
- Neonatal SEPSIS, Necrotizing Enterocolitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Clinical Research Centre, MalaysiaUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neonates with suspected LONS and/or NEC | – | Other: No interventionA 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. |
| Healthy neonates | – | Other: No interventionA 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. |
Who may qualify
- Ages
- 72 hours to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention will be given to study subjects. Only blood will be obtained from study subjects. | Other | Healthy neonates, Neonates with suspected LONS and/or NEC |
Primary outcome
Diagnostic utilities of biomarkers of interest in diagnosing LONS
Time frame: 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
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirin Hui Tan principal investigator
Clinical Research Centre, Sarawak General Hospital, Malaysia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal SEPSIS and Necrotizing Enterocolitis, run by Clinical Research Centre, Malaysia at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shirin Hui Tan (+6082-276820, shirin_hui88@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic utilities of biomarkers of interest in diagnosing LONS (time frame: Hour 0 to 72). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.