|- candidate number||3143|
|- NTR Number||NTR1257|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-mrt-2008|
|- Secondary IDs||2007-149 METC|
|- Public Title||Reducing the prescription of antibiotics in newborn infants, suspected for an early onset sepsis.|
|- Scientific Title||Reducing the prescription of antibiotics in newborn infants, suspected for an early onset sepsis.|
|- ACRONYM||RAP study|
|- hypothesis||Is it possible with the course of cytokines in the first two days of life to start antibiotics selectively in infants suspected for an EOS (early onset sepsis) and to stop prescribing antibiotics in infants who already receive antibiotics|
|- Healt Condition(s) or Problem(s) studied||Early onset sepsis , Neonatal sepsis, Cytokines, Antibiotics|
|- Inclusion criteria||1. A newborn infant who is admitted to a pediatric or to a maternity ward and in whom an EOS cannot be excluded. |
2. Informed consent of the parent or legal guardian.
|- Exclusion criteria||1. Newborn infant older than 6 hours.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||3-jan-2008|
|- planned closingdate||1-jan-2011|
|- Target number of participants||900|
|- Primary outcome||proven EOS vs. no EOS|
EOS is defined as a positive blood culture taken within 48 hours after birth. Cultures positive for organisms considered as contaminants (such as corynebacterium) are excluded.
|- Secondary outcome||Secondary outcome: |
1. Proven EOS,
2. Clinical EOS,
3. Suspected EOS but afterwards no EOS,
4. No EOS and never suspected for an EOS.
|- Timepoints||Cytokine measurements:|
NS: 5 ml cord blood will be taken for cytokine measurements and analyzed for DNA polymorphism, putatively involved in EOS.
T1: Direct post partum when blood is taken for clinical diagnostics 0.2 ml will be taken for cytokine and CRP measurements.
T2: Four hours after T1 when blood is taken for clinical diagnostics 0.2 ml will be taken for cytokine measurements.
T3: 24 hours post partum when blood is taken for clinical diagnostics 0.2 ml will be taken for cytokine and CRP measurements.
T4: 48 hours post partum when blood is taken for clinical diagnostics 0.2 ml will be taken for cytokine and CRP measurements.
|- Trial web site||www.rapstudy.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. Paul Broek, van den|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Paul Broek, van den|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|Doelmatigheidsfonds University Medical Center Groningen |
|- Brief summary||Rationale: |
Due to suspected Early Onset Sepsis (EOS) newborn infants receive frequently antibiotics which have several side effects. EOS, defined as a sepsis starting within the first 2 days of life, is a severe and life-threatening disease. The mortality when untreated is around 100%. EOS is difficult to diagnose. The first clinical symptoms of a sepsis are non-specific and may be subtle. The presence or absence of maternal risk factors may be related to EOS, but do not predict the occurrence of an EOS. Common laboratory parameters are not sensitive enough to predict or exclude the diagnosis of EOS. The golden standard to detect a neonatal sepsis is a blood culture but results are definite only after 48-72 hours.
Given the difficulty of a clinical diagnosis of EOS, immediately starting antibiotic therapy is the recommended approach in all infants with suspected EOS. This approach will cause, in retrospect, “unnecessary” treatment in many infants.
To develop a new diagnostic model to reduce unnecessary antibiotic treatment, which can be tested in the near future.
Non-therapeutic observational study.
1. Inborn infants admitted to a pediatric or a maternity ward direct postnatally and in whom an EOS cannot be excluded.
2. Inborn infants admitted to a pediatric ward direct for glucose measurements and who is not suspected for an EOS.
Main study parameters/endpoints:
The primary outcome parameters are:
EOS versus no EOS.
The primary study parameters are the course of cytokines (IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, TNF-á, IFN-ã, RANTES en IP-10) direct post partum, 4 hours post partum, 24 hours post partum and 48 hours post partum.
|- Main changes (audit trail)|
|- RECORD||26-mrt-2008 - 26-mei-2008|