Cefazolin Pharmacokinetics: Elimination Clearance in Neonates
Condition: Prophylaxis
Study type: Interventional
Phase: Phase 4

Summary: 
      To document cefazolin disposition (concentration/time profile, protein binding, metabolism,
      renal elimination characteristics) and its covariates in neonates following intravenous
      administration of the drug at induction of anesthesia, prior to an invasive procedure

      To evaluate if optimalisation of cefazolin dose regimen during neonatal life is needed
    

Detailed description: 
      Prospective, single-center, open label study on the pharmacokinetics of iv cefazolin
      administration in neonates admitted in the neonatal intensive care unit, University Hospitals
      Leuven, Belgium.

      Patients will be included after signed informed consent of the parents.

      Our aim is to include 40 neonates. Cefazolin has been selected for this study as it is
      routinely administered in neonates undergoing invasive procedures in our unit. At this stage,
      we only have the intention to document pharmacokinetics and covariates based on the current
      clinical practice and therefore will not interfere with either clinical indication, or with
      dosing as prescribed by the attending physician.

      Drug administration and collection of samples will be obtained to the current clinical and
      nursing standard procedures.

      Routine clinical care for scheduled invasive procedures in neonates in our unit is
      intravenous administration of cefazolin as follows:

        -  50 mg/kg, 3 times a day

        -  an extra dose of 50mg/kg is given after 3 hours for operations longer than 3 h

        -  each time one dose/day is excluded for neonates with body weight <2000 g and postnatal
           age (PNA) <7 days,

        -  for invasive operations (e.g. open-heart surgery, laparotomy) the prophylactic
           administration of cefazolin may be continued for 3-5 days following the completion of
           surgery.

      The antibiotic agent should be administered 30 minutes to 1 hour prior to the start of
      surgery so that adequate antibiotic levels. Cefazolin is administered to the neonate, through
      a peripherally inserted venous catheter, during 30 minutes.

      Blood will be collected in heparinised tubes through an indwelling arterial line, or deep
      venous access, always when other routine blood samples are collected for clinical purposes
      (pO2, pCO2, pH).

      Urine samples will be collected through a bladder catheter in patients in whom a bladder
      catheter is available for clinical indications.

      Pharmacokinetic analysis A population pharmacokinetics approach will be used, hereby
      comparing the data on PK already reported in adults or older children and the newly collected
      data during neonatal life.
    

Intervention name(s): Cefazolin
Intervention type(s): Drug
Intervention description(s): iv cefazolin (50mg/kg, 3 times a day) will be given as a routine prophylaxis treatment
Other intervention name(s): Kefzol
Intervention MeSH terms: Cefazolin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cefazolin; prophylaxis; pharmacokinetics; newborn