Infection control and hospital epidemiology · 2026
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.
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Marsubrin Putri Maharani Tristanita, Sjahrullah Muhamad Azharry Rully, Widyasari Nurul Fajri, Oswari Jessica Sylvania, Roeslani Rosalina Dewi, Iskandar R Adhi Teguh Permana, Sukarja Distyayu, Kautsar Ahmad, Rohsiswatmo Rinawati
Аннотация
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.
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.