Methods for peripherally inserted central catheter measurement in neonates and children: protocol for a randomized controlled trial

Abstract

Background: Peripherally inserted central catheters (PICC) are widely used in neonates and children requiring intravenous therapy due to their clinical advantages. However, incorrect catheter tip positioning remains frequent and may lead to serious complications. The conventional anatomical landmark–based measurement presents important accuracy limitations. A new approach, the Tomazoni method, has been proposed to improve tip positioning, but current evidence is limited to a small single-center study, highlighting the need for further investigation in broader populations. The objective is to describe a study protocol designed to prospectively evaluate the effectiveness of the Tomazoni measurement method for PICC insertion in neonates and children.

Methods: Study protocol for a pragmatic, parallel-group, double-blind randomized clinical trial. Eligible participants will be neonates and children requiring upper-limb PICC insertion. The control group will undergo the traditional measurement method, while the experimental group will receive the Tomazoni method. Data will be collected using an instrument including patient, procedure, and catheter characteristics. Analyses are planned to involve frequency distributions, association tests, and relative risk. The primary outcome will be the initial catheter tip position.

Conclusions: The findings are expected to contribute to the development of safer and more effective practices in PICC insertion in children and neonates’ populations, supporting patient safety and quality of care in critical neonatal and pediatric environments.