Objective To determine whether 2% chlorhexidine gluconate–70% isopropyl alcohol (CHX–IA) is superior to 10% aqueous povidone–iodine (PI) in preventing catheter-related blood stream infection (CR-BSI) when used to clean insertion sites before placing central venous catheters (CVCs) in preterm infants.
Design Randomised controlled trial.
Setting Two neonatal intensive care units (NICUs).
Patients Infants <31 weeks’ gestation who had a CVC inserted.
Interventions Insertion site was cleaned with CHX–IA or PI. Caregivers were not masked to group assignment.
Main outcome measures Primary outcome was CR-BSI determined by one microbiologist who was masked to group assignment. Secondary outcomes included skin reactions to study solution and thyroid dysfunction.
Results We enrolled 304 infants (CHX–IA 148 vs PI 156) in whom 815 CVCs (CHX–IA 384 vs PI 431) were inserted and remained in situ for 3078 (CHX–IA 1465 vs PI 1613) days. We found no differences between the groups in the proportion of infants with CR-BSI (CHX–IA 7% vs PI 5%, p=0.631), the proportion of CVCs complicated by CR-BSI or the rate of CR-BSI per 1000 catheter days. Skin reaction rates were low (<1% CVC insertion episodes) and not different between the groups. More infants in the PI group had raised thyroid-stimulating hormone levels and were treated with thyroxine (CHX–IA 0% vs PI 5%, p=0.003).
Conclusions We did not find a difference in the rate of CR-BSI between preterm infants treated with CHX–IA and PI, and more infants treated with PI had thyroid dysfunction. However, our study was not adequately powered to detect a difference in our primary outcome and a larger trial is required to confirm our findings.
Trial registration This study was registered with the EU clinical trials register before the first patient was enrolled (Eudract 2011-002962-19). (https://www.clinicaltrialsregister.eu)
- randomised trial
- catheter related blood stream infection
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