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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Contributors EAK made substantial contributions to the conception and design of the study. She oversaw patient enrolment and conducted trial at the National Maternity Hospital and Coombe Women and Infants University Hospital. She also acquired the data. Together with CPFOD, she had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. She wrote the first draft of the manuscript. AOS oversaw patient enrolment and conducted trial at the Coombe Women and Infants University Hospital and acquired the data for infants enrolled at that site. JM made substantial contributions to the design of the study. He was the primary investigator at the Coombe Women and Infants University Hospital. ART made substantial contributions to the design of the study. She critically reviewed the trial protocol and final manuscript for important intellectual content. SJK made substantial contributions to the design of the study. She determined the primary outcome for all infants enrolled in the study. She critically reviewed the trial protocol and final manuscript for important intellectual content. CPFOD conceived and designed the study. He was the principal investigator overseeing the trial. He was the primary investigator at the National Maternity Hospital. Together with EAK, he had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. He redrafted the manuscript and revised it for important intellectual content. All authors approved this version of the manuscript and are in agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding The trial was funded by the National Children’s Research Centre (NCRC), Dublin, Ireland.
Patient consent Parental/guardian consent obtained.
Ethics approval Research ethics board at the National Maternity Hospital and Coombe Women and Infants University Hospital. In addition, the study protocol was approved by the Health Products Regulatory Authority in Ireland.
Provenance and peer review Not commissioned; externally peer reviewed.
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