Spafford 1994.
Methods | Double‐blind, randomised, controlled trial. A locally‐developed randomisation scheme was used. Sealed envelopes were used. Blinding of randomisation (allocation concealment): yes Blinding of intervention: yes Completeness of follow up: yes Blinding of outcome measurement: yes | |
Participants | Single neonatal unit trial in Rochester, New York, United States from April 1991 to June 1992. All infants who had a central venous catheter inserted were considered eligible for inclusion. Catheters were inserted after a negative blood culture had been obtained and there was no evidence of acute infection. Exclusion criteria included renal dysfunction (not defined), and infants with Broviac, Hickman or umbilical venous catheters (i.e., all catheters in study subject were peripherally inserted central catheters). Group allocation was maintained for subsequent catheters. Catheters were used primarily for parenteral nutrition administration but some were also used for intravenous medication administration. Seventy infants (35 in each group) were included. No details about gestational age and birth weight are provided. | |
Interventions | Treatment Group; parenteral nutrition solution containing 25 micrograms of vancomycin per mL (n=35). Control Group; parenteral nutrition with no vancomycin (n=35). | |
Outcomes | Mortality ‐ timing of death not specified). Proven bacterial septicaemia ‐ CONS only. Duration of hospital stay. Number of resistant organisms causing infection. Number of resistant organisms colonising infants in study. Neurodevelopmental outcome ‐ brain stem auditory evoked potentials. | |
Notes | We attempted, unsuccessfully, to contact the first author for further details and data. Blood urea nitrogen, creatinine and vancomycin levels were measured weekly and monitored by a physician not involved in patient care. Infants were investigated for sepsis if they had temperature instability, increased oxygen and ventilatory requirements, increased number or severity of apnoea or bradycardia, feeding intolerance, lethargy, or blood pressure instability. Investigation of suspected sepsis included blood cultures obtained from a peripheral vein and drawn through the central venous catheter. On removal, catheters were sent for microbiologic evaluation (a drop of rinse solution onto blood agar or catheter tip rolled across surface of blood agar plate). Catheter‐related sepsis was defined as catheter specimen containing at least 10 times the concentration of the same pathogen isolated from the peripheral sample. Brain stem auditory evoked potentials were obtained prior to discharge. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |
CONS: coagulase‐negative Staphylococcus; CRP: C‐reactive protein; FBC: full blood count; SE: standard error; VLBW: very low birth weight