Effectiveness of Tomazoni Measurement Method for Central Catheter Tip Positioning in Neonates: A Randomised Controlled Trial.
Verbatim Formal Study Abstract
Accurate peripherally inserted central catheter (PICC) tip positioning in neonates remains challenging, with high rates of malposition reported using traditional measurement methods.
To evaluate the effectiveness of the Tomazoni method for PICC positioning in neonates compared with the traditional method.
Pragmatic, parallel-group randomised clinical trial with stratified block randomisation, conducted in a neonatal intensive care unit in Brazil between June 2024 and April 2025.
Of 62 randomised procedures, 55 were evaluable (27 in the experimental group, 28 in the control group). Central positioning was achieved in 21 of 27 procedures (77.8%) in the experimental group versus 5 of 28 (17.9%) in the control group (p < 0.001). PICC insertion procedures assessed using the Tomazoni method were 4.36 times more likely to achieve central tip placement (RR = 4.36; 95% CI: 1.91-9.88). Catheter withdrawal was required in 3 of 27 procedures (11.1%) in the experimental group versus 16 of 28 (57.1%) in the control group (p = 0.001; RR = 0.19; 95% CI: 0.06-0.59).
The Tomazoni measurement method was associated with substantially higher rates of central PICC tip positioning and reduced need for catheter withdrawal compared with the traditional method.
The Tomazoni method offers a reproducible, low-cost measurement strategy that can be implemented in neonatal intensive care units to improve catheter positioning accuracy and reduce procedure-related manipulations, with potential implications for patient safety. The trial, titled 'Comparison between measurements of peripherally inserted central catheters in children and newborns', was registered in the Brazilian Clinical Trials Registry under the identifier RBR-55zwb45.
This trial is registered in the Brazilian Clinical Trials Registry (ReBEC) under the identifier RBR-55zwb45.