primary outcome:
Antiseptic solutions for skin preparation during central catheter insertion in neonates
Proven CRBSI using absolute rates of infants. We employed the definition of CRBSI based on the CDC and the Infectious Disease Society of America (IDSA) criteria (CDC 2011; Manian 2009). This included the growth of an identical organism from cultures of central catheter parts upon removal or from blood withdrawn from it (in large catheters), and blood withdrawn from peripheral veins with the presence of clinical signs and symptoms of sepsis in the absence of another infection from a distant site. Additionally, the ratio of the colony count of microorganisms grown from the central catheter parts to the colony count of blood from the peripheral vein had to be at least 3:1, and the growth from the central catheter parts or blood withdrawn from it had to occur at least two hours before any detected growth in the peripheral blood sample. In the case of neonatal deaths, there is a positive culture from sterile sites (e.g. cardiac, cerebrospinal fluid, liver, and spleen) at autopsy. We chose CRBSI as it has higher specificity in confirming that the catheter is the source of infection compared to CLABSI. We accepted trials that used overlapping definitions of CRBSI and CLABSI under this outcome if CRBSI was not independently reported. Catheter segment culture is costly, has a high false‐positivity (Kitano 2018), and is no longer a routine investigation in most NICUs. Furthermore, not all infants with probable CRBSI have their CVC removed and cultured, and it is not feasible to withdraw blood for culture from the small neonatal PICC (Bentlin 2015). CLABSI using absolute rates of infants. We used the definition of CLABSI in patient ≤ one‐year‐old, adapted from the previous version of CDC 2023. The definition included all the following criteria:presence of at least one of the following:fever (more than 38 ºC core temperature);hypothermia (less than 36 ºC core temperature);apnoea or bradycardia;positive peripheral blood culture not related to an infection at another site;the same common commensal organism listed in the CDC common commensal organism list is cultured from two or more blood cultures drawn on separate occasions within 24 hours duration.presence of a central line on the day of the event or in the last 24 hours. Probable or clinical sepsis of all causes measured by the authors of individual trials as absolute rates of infants up to 24 hours after removal of the catheter. We used a broad definition of probable or clinical sepsis adapted from Wynn 2014. The criteria excluded the cases of proven sepsis and included all the following criteria:the presence of at least one of the following:fever (more than 38 ºC core temperature);hypothermia (less than 36 ºC core temperature);apnoea or bradycardia;no positive blood culture;a combination of at least two clinical or laboratory signs of sepsis;no apparent source of infection from another site;the clinical features have led to the institution of treatment for sepsis.All‐cause mortality before discharge from the NICU.Chemical burns or contact dermatitis, measured using a scoring system or by clinical judgement as described by the trial authors during or after the application of the antiseptic solution.