2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheterisation: the ARCTIC randomised controlled feasibility trial.

OBJECTIVE: Catheter-related sepsis (CRS) is a major complication with significant morbidity and mortality. Evidence is lacking regarding the most appropriate antiseptic for skin disinfection before percutaneous central venous catheter (PCVC) insertion in preterm neonates. To inform the feasibility and design of a definitive randomised controlled trial (RCT) of two antiseptic formulations, we conducted the Antiseptic Randomised Controlled Trial for Insertion of Catheters (ARCTIC) feasibility study to assess catheter colonisation, sepsis, and skin morbidity. DESIGN: Feasibility RCT. SETTING: Two UK tertiary-level neonatal intensive care units. PATIENTS: Preterm infants born <34 weeks' gestation scheduled to undergo PCVC insertion. INTERVENTIONS: Skin disinfection with either 2% chlorhexidine gluconate (CHG)-aqueous or 2% CHG-70% isopropyl alcohol (IPA) before PCVC insertion and at removal. PRIMARY OUTCOME: Proportion in the 2% CHG-70% IPA arm with a colonised catheter at removal. MAIN FEASIBILITY OUTCOMES: Rates of: (1) CRS, catheter-associated sepsis (CAS), and CRS/CAS per 1,000 PCVC days; (2) recruitment and retention; (3) data completeness. SAFETY OUTCOMES: Daily skin morbidity scores recorded from catheter insertion until 48 hours post-removal. RESULTS: 116 babies were randomised. Primary outcome incidence was 4.1% (95% confidence interval: 0.9% to 11.5%). Overall catheter colonisation rate was 5.2% (5/97); CRS 2.3/1000 catheter days; CAS 14.8/1000 catheter days. Recruitment, retention and data completeness were good. No major antiseptic-related skin injury was reported. CONCLUSIONS: A definitive comparative efficacy trial is feasible, but the very low catheter colonisation rate would make a large-scale RCT challenging due to the very large sample size required. ARCTIC provides preliminary reassurance supporting potential safe use of 2% CHG-70% IPA and 2% CHG-aqueous in preterm neonates. TRIAL REGISTRATION NUMBER: ISRCTN82571474.

A novel approach to standardised recording of bleeding in a high risk neonatal population.

BACKGROUND: Bleeding assessment tools have been developed in other specialties to standardise the recording of bleeding for clinical haemostatic outcomes in transfusion trials, but such tools have not been developed for routine use in neonatology. AIM: The objective of this study was to develop, refine and evaluate a neonatal bleeding assessment tool (NeoBAT) to standardise the clinical recording of bleeding in premature and term neonates in an intensive care setting. METHODS: This prospective neonatal international multicentre study included all episodes of bleeding in infants admitted to the intensive/high dependency care nursery over a 2-4-week period. The NeoBAT was developed to record neonatal bleeding episodes. We tested its reliability and reproducibility with duplicate assessments. RESULTS: Duplicate assessments revealed 98% concordance. Bleeding occurred in 25% (37/146) of infants overall and was most common in preterm infants. 11% (16/146) infants had major/severe bleeds, 1% (2/146) moderate and 13% (19/146) minor bleeds. CONCLUSIONS: Bleeding is common in premature and term neonates admitted to intensive/high dependency care nurseries. This novel bleeding assessment tool facilitates prospective recording of bleeding events in neonatal intensive care settings and may allow standardised bleeding assessments in this high risk population.