The efficacy of needleless connector designs (split septum vs mechanical valve) on preventing central line-associated bloodstream infection (CLABSI) in very preterm or very low-birth-weight neonates: a randomized clinical trial
In brief
Split-septum connectors cut CLABSI rate to 3 per 1,000 catheter days versus 16 per 1,000
In a randomized trial of 60 very preterm or very low-birth-weight infants, split-septum needleless connectors reduced bloodstream infection incidence from 16.2 to 3.0 per 1,000 catheter days. Although the difference did not reach statistical significance, mortality and length of stay were lower in the split-septum group, suggesting a potential safety advantage that warrants larger studies.
- Journal
- Infection control and hospital epidemiology (Q1)
- Published
- 6 August 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Putri Maharani Tristanita Marsubrin, Muhamad Azharry Rully Sjahrullah, Nurul Fajri Widyasari, Jessica Sylvania Oswari, Rosalina Dewi Roeslani, R Adhi Teguh Permana Iskandar, et al.
- PMID
- 42557878
- DOI
- 10.1017/ice.2026.10447
Why clinicians should know about it
- Picked for Neonatology (top studies of the week, 9 August 2026): Editorial correction notice, no primary data
- Picked for Microbiology (medical) (top studies of the week, 9 August 2026): Split septum needleless connector reduced CLABSI incidence
Abstract
OBJECTIVE: To determine whether split septum needleless connector prevent central line-associated bloodstream infection (CLABSI) better than mechanical valve in very preterm or very low-birth-weight (VLBW) neonates. DESIGN: This is an open-label, parallel, randomized controlled trial. Participants were followed up to 48 hours after central line removal for the primary outcome. SETTING: This is a single-center study conducted at level III neonatal intensive care unit in public tertiary hospital. PARTICIPANTS: Very premature or VLBW neonates requiring central access. INTERVENTION: Participants were randomized to receive either a split septum or mechanical valve needleless connector. PRIMARY OUTCOME: The primary outcomes were CLABSI incidence rate and the estimated hazard ratio of CLABSI between the two groups. RESULTS: A total of 60 neonates were included in the analysis, in which 30 neonates were allocated to each intervention (split septum) (mean±SD gestational age, 27.37 ± 7.7 weeks; 15 [50%] male) and control (mechanical valve) group (mean±SD gestational age, 30.27 ± 2.7 weeks; 17 [56.7%] male). The CLABSI incidence rate was lower in the intervention group (3.0 vs 16.2 per 1,000 catheter days). The adjusted hazard ratio for the intervention compared to control group was 0.153 (95% CI 0.02-1.52; P = .109). Although not statistically significant, the control group demonstrated higher CLABSI-related mortality (7% vs 0%), length of stay (49.8 ± 24.2 vs 42.3 ± 23.8), and hospital cost (130.5 (79.4-215.9) vs 104.1 (86.4-152.7). CONCLUSIONS: Split septum demonstrated a trend in lower incidence of CLABSI. This result should be weighed carefully in determining the needleless connector type best suited for very preterm or VLBW neonates.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.