The aim of this study is to evaluate the diagnostic value of sCD14-ST in the diagnosis of neonatal sepsis. The secondary aim is to evaluate whether serial measurement of sCD14-ST after suspected sepsis onset is of additive predictive value for the…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference in plasma sCD14-ST level between
infants with and without neonatal sepsis.
Secondary outcome
- the difference in plasma sCD14-ST level over time between infants with and
without neonatal sepsis.
- discordance in positive and negative outcomes of molecular blood culturing
(IS-pro) compared to outcomes of whole blood culturing between infants with and
without neonatal sepsis
- difference in intestinal microbiota composition between infants who received
antibiotics less than 72 hours compared to infants who received antibiotics
longer than 72 hours.
Background summary
Early diagnosis is essential in neonatal sepsis as the signs and symptoms are
nonspecific. Delays in diagnosis may lead to progressive deterioration.
Although blood culture is the gold standard for the diagnosis, false-negative
results and long incubation period limits the use of blood culture in neonatal
sepsis. To avoid unnecessary treatment of non-infected neonates, an early,
sensitive and specific laboratory test would be helpful to guide clinicians in
neonatal units to decide whether or not to start antibiotics. Soluble CD14
subtype (sCD14-ST) is a promising candidate biomarker for this purpose.
sCD14-ST has high sensitivity and specificity for the diagnosis of neonatal
sepsis and is potentially superior to C-reactive protein (CRP) and
procalcitonin (PCT). However, data are limited, and a clear cut-off value with
a high negative predictive value is lacking.
Study objective
The aim of this study is to evaluate the diagnostic value of sCD14-ST in the
diagnosis of neonatal sepsis. The secondary aim is to evaluate whether serial
measurement of sCD14-ST after suspected sepsis onset is of additive predictive
value for the diagnosis neonatal sepsis in this vulnerable group.
Study design
Prospective observational cohort study.
Study burden and risks
Participation in the study involves no risks and a minimal burden for the
included patients. All included patients are treated based on standard clinical
care. No extra punctures are performed for study purposes. In total an extra 1
or 2 mL (dependent on duration of pregnancy) of blood is drawn together with
the standard blood tests. No treatment decisions are made based on the plasma
levels of sCD14-ST. Additionally, feces samples will be collected at 48 hours,
10 days, 3 and 12 months after birth.
Jan Tooropstraat 164
Amsterdam 1061AE
NL
Jan Tooropstraat 164
Amsterdam 1061AE
NL
Listed location countries
Age
Inclusion criteria
• Admitted to the Neonatal unit
• Undergoing sepsis evaluation according to the Dutch early onset neonatal
sepsis guideline, or local late-onset sepsis guideline.
• Informed consent of parents or legal guardian(s)
Exclusion criteria
• Confirmed intrauterine infection (toxoplasmosis, rubella, cytomegalovirus,
syphilis and herpes)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61402.100.17 |