Efficacy and safety of Russian-made peripherally inserted central catheters in premature infants: a randomized clinical trial

Background. Peripherally inserted central catheters (PICCs) are widely used in neonatology to provide durable central vascular access for vasoactive agents and high-osmolarity solutions. PICC placement via peripheral vein reduces the risk of catheterization-related complications and catheter-associated infections. In Russia, a domestic analogue of polyurethane catheter of foreign manufacture has been registered. However, no prospective clinical comparisons are available in the literature. Objective. To evaluate clinical efficacy and safety of single-lumen polyurethane PICCs without stylets from a domestic manufacturer (DM) compared to analogous device from a foreign manufacturer (FM) in preterm neonates. Material and methods. A prospective randomized blinded single-center study was conducted. All PICCs were inserted by the same anesthesiologist. Catheters were covered with opaque dressings to conceal the manufacturer. Daily examinations and functional assessments were performed according to standard protocol. Results. There were 50 neonates between October 2024 and February 2025; 47 ones were included in final analysis (DM — 23, FM — 24). Both groups were comparable in anthropometric and clinical characteristics. Upper-extremity vein insertion was performed in 52.1% (DM) and 50.0% (FM) of cases. Difficult advancing the catheter occurred with similar frequency (DM — 47.8%, FM — 41.7%; p=0.772). The need for water-soluble contrast to verify catheter tip position was significantly higher in the FM group (25.0% vs. 0%; p=0.022). No fever was observed within 72 hours after insertion. Phlebitis occurred in 12.5% (FM) and 0% (DM) (p=0.234) of cases, respectively. Other complications (soft tissue edema, hydrothorax, tamponade) occurred in 13.1% (DM) and 12.5% (FM) of cases, respectively. Conclusion. In preterm neonates, PICCs from domestic manufacturer are non-inferior to those from foreign manufacturer in terms of clinical efficacy and safety. FM devices more frequently require contrast administration for radiographic tip verification. Further studies with larger sample sizes are warranted.