Study | Reason for exclusion |
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Baier 1998 | Wrong population. Study included infants without central venous catheters. Data specifically relating to the subgroup of infants with central venous catheters (12 of 38 subjects) were not available. We attempted, unsuccessfully, to contact trial investigator for these data. Randomised controlled trial studying the addition of vancomycin to parenteral nutrition (25 mcg/mL) versus no addition of vancomycin in 38 very low birth weight infants in the first 2 weeks of life. Infants were stratified by birth weight. Evaluation for sepsis was at the discretion of the treating physicians. Catheter tip was cultured following removal. Significant reductions in CONS bacteraemia, total bacteraemia, and length of hospital stay were reported. No vancomycin‐resistant CONS or enterococci were isolated during the study. |
Garland 2005 | Wrong intervention. Studied the effect of using heparinised saline central venous catheter "lock" solution with or without the addition of vancomycin to the solution. The lock solution was withdrawn following a pre‐specified dwell time. Systemic antibiotic administration was not a part of the study design. Randomised controlled trial involving 85 infants with central venous catheters (42 treatment, 43 control). Serum vancomycin levels were monitored in the first 73 patients. Only 1 infant had vancomycin detected in serum. Catheters were not locked when infants were receiving systemic vancomycin therapy or continuous infusions of insulin or vasoactive drugs. Surveillance rectal and axillary swabs were obtained at study entry and at catheter removal. No vancomycin‐resistant organisms were identified. On clinical suspicion of sepsis blood cultures were collected from a peripheral vein and from the catheter; the catheter hub was also cultured. Catheters were removed at the discretion of the treating neonatologist. Bloodstream infections were classified as "definite CRBSI", "probable CRBSI", or "bloodstream infection without a source" according to degree of correlation between organisms identified in peripheral blood culture, catheter blood culture, and catheter hub or tip culture. There were 7 bloodstream infections in the treatment group vs 18 in the control group (RR 0.40; 95% CI: 0.19‐0.85; P = 0.01). This difference was mainly due to a reduction in the treatment group of definite CRBSI. |
Kacica 1994 | Wrong population. Study appears to have included infants without central venous catheters. Inclusion criteria include "intravenous access needed for parenteral nutrition". Data specifically relating to the subgroup of infants with central venous catheters were not available. We attempted, unsuccessfully, to contact trial investigator for these data. Non‐blinded randomised, controlled trial comparing the effect of a continuous low dose vancomycin infusion (25 mcg/mL), added to the parenteral nutrition, versus no treatment in 141 VLBW infants (71 in treatment group, 70 in control). All were less than 2 weeks of age and not on antibiotic treatment at recruitment. Vancomycin was ceased when parenteral nutrition was no longer required or the infant reached 1 month of age. All infants had weekly serum creatinine level and urinalysis and those in the treatment group also had weekly full blood counts and monitoring of vancomycin levels. On suspicion of sepsis aerobic and anaerobic blood cultures were collected. Skin and rectal surveillance swabs were obtained at enrolment and at termination of the protocol. Infants in the treatment group had fewer evaluations for sepsis (44 vs 76; P < 0.05), fewer positive blood cultures (2 infants vs 26 infants; P < 0.001), shorter duration of catheterisation (21.4 +/‐ 14.3 days vs 27.8 +/‐ 21.6 days; P < 0.0001), and less time to full feeds (22.2 +/‐ 15.5 days vs 26.5 +/‐ 18.9 days; P < 0.01). No "shift to" vancomycin resistance was observed. |
Moller 1993 | Wrong population. As the second phase of a three‐phase study, VLBW infants with any form of intravenous access were randomised to either prophylactic vancomycin (10 mg/kg/day in two doses) or no treatment. Published in German. The first phase involved the introduction of hygiene measures to the care of all VLBW infants. This had no significant impact on sepsis rates. Phase 2 involved the randomisation of all VLBW babies to treatment and control groups, as above. Nurses and "intensive care doctors" were blinded but the treating consultants were informed of group assignment. This showed a significant difference in rates of CONS sepsis (6/21 in control group vs 0/20 in treatment group; P = 0.012) but no significant difference in rates of Gram‐negative sepsis. Therefore, in phase 3 all VLBW infants were treated with vancomycin prophylaxis and those with pathogenic Gram‐negative organisms isolated from stool cultures were given a single dose of oral cefixime. |
Rackoff 1995 | Wrong population. Randomised, controlled trial of heparin‐vancomycin vs heparin flush solutions in paediatric patients with central venous catheters. Patients had cancer or were receiving parenteral nutrition for bowel disorders. |
CONS: coagulase‐negative Staphylococcus; CRBSI: catheter‐related bloodstream infection; RR: relative risk; CI: confidence interval; VLBW: very low birth weight