This study aimed to quantify the impact of a novel device-based approach to UC securement and stabilization on rates of UC migration, malposition leading to premature discontinuation, and CLABSI. Here, we found a significantly lower incidence of UVC migration leading to discontinuation, as well as significantly fewer instances of UC migration overall, in the LifeBubble group compared to the adhesive control group. These findings demonstrate that the LifeBubble device can provide a significant clinical advantage in the prevention of UC migration and migration leading to early discontinuation. This report is the first to demonstrate the potential of an intervention to increase UC stability in neonates.

UCs are an essential tool for medication delivery and monitoring in neonates, yet high complication rates exist in part due to the lack of reliable and standardized securement methods, and because of the unique aspects of UCs when compared to other catheters: placement into vessels end on and the fact that these vessels are part of a non-vital fetal remnant that becomes desiccated. The only other comparable conditions for central access in medicine are in serious burn patients, which can require catheter placement through devitalized tissue. Studies for such central catheters demonstrate CLABSI rates of 15.4–20.6 per 1000 catheter days [23, 24].

The decrease in UVC migration incidence seen in this study from 39.3% (adhesive control group) to the 5.3% (LifeBubble group) (Table 2) remained statistically significant even when adjusting for significant differences in the two groups, including birth weight, gestational age at birth, presence of both UCs, and congenital heart disease. The same is true for the decrease in UAC migration (23.0% adhesive control to 7.0% LifeBubble) when adjusted for differences in the two groups, As might be expected from the individual UVC and UAC migration results, the reduction in combined UC migration incidence was also statistically significant, with the reduction likely driven more by the effect on UVC migration. Notably, the number needed to treat to prevent UVC discontinuation in this study is only 4, an impressively low number that suggests that use of the LifeBubble device could have a significant impact on clinical care.

Migration may be a cause of CLABSIs in NICU patients. UC sites are currently unprotected and non-sterile. If a catheter exposed to this bacteria-prone environment migrates deeper, bacteria on the catheter surface could be directly carried into the patient’s bloodstream, however, UC migration inward and linkage to increased risk for CLABSI has yet to be demonstrated. While this study did not include any CLABSIs to report, such hospital-associated infections remain a key focus of quality improvement metrics across the US healthcare system. Catheter migration and dislodgement under the current standard of care may lead to variations in NICU policies for family holding and prone positioning with UCs, as well as variations in practice between providers or nursing staff within a NICU.

The ability to prevent migration and discontinuation could also impact dwell time and the need for short-term alternative central catheters. These replacement catheters come with their own risks at initial insertion and throughout use. Commonly used PICCs have been shown to have increasing CLABSI risks after the first 14 days of use [25]. Decreased UC migration has the potential to lead to increased maximum dwell times, which could extend through the end of a patient’s highest acuity period and eliminate the need for additional central catheter insertion. In some patients, a second central catheter may be entirely avoided with increased UVC dwell time.

The decrease in umbilical catheter migration, particularly UVC migration, would likely directly translate, over many patients, to the prevention of serious adverse events in these neonatal patients. Intracardiac migrations can be fatal due to complications including intracardiac thrombosis and myocardial perforation, while migrations outward can lead to severe liver damage [26]. A larger study with more patients, powered to detect a difference in these rarer life-threatening effects, would be necessary to assess the potential prevention of such downstream complications.

The results of this study, as well as past studies, demonstrate lower migration risks associated with UACs when compared with UVCs [10]. While the reason for this is not firmly established, generally UACs are used for monitoring blood pressure and arterial blood gasses, while UVCs are used for the active delivery of fluids, nutrition, and medications. This may result in increased frequency and duration of UVC handling, leading to increased opportunity for catheter movement. Additionally, the larger region of appropriate positioning for UACs (T6-9) means that movement is less likely to lead to mispositioning. In the future, these UC dwell times could both be safely extended based on the ability of new technology to enable catheter securement and insertion site protection while limiting complication risks.

Patients in the LifeBubble group also had lower overall UC migration rates despite the significant difference in congenital heart disease patients. Congenital heart disease patients have been shown to be at higher risk for UVC complications [1, 27]. This could be due to more extensive testing and procedures that make a patient more prone to movement, longer durations of time in which central catheters are needed, the anatomy of the heart itself, or the physical movement of the heart itself in patients undergoing cardiac repair.

A leading reason for the success of the LifeBubble group is likely the mechanism of mechanical securement. Adhesives are prone to failure after exposure to moisture or repeated/excessive movement. Meanwhile, the LifeBubble uses a silicone strap to lock the UC into place without evidence of impeded catheter flow. The insertion site is also protected by the body of the device, while vents allow for stump desiccation and visualization [22, 28]. Furthermore, standardization has been recognized as a key component to quality improvement and patient safety [29,30,31]. The current standard of care for UC securement and maintenance requires subjective behavior of the clinical team which is prone to variation in system stability and resulting clinical outcomes.

There was a statistically significant difference in birth weights between the standard adhesive securement and LifeBubble groups, with larger birth weights in patients in the LifeBubble group. This was due to the non-randomized nature of the study and apparent bias in the choice of securement method. While this difference does not impact the conclusions drawn from the study results by logistic regression, a smaller shift in catheter positioning will have a proportionally larger impact on patients of lower birth weight. Lower birth weight patients may therefore be more likely to experience clinically significant migration from small catheter movement, emphasizing the importance of umbilical catheter position stability. The relatively low proportion of patients classified as very low birth weight (<1500 g) and the exclusion of extremely low birth weight (<1000 g) patients are relevant limitations of the study. The efficacy of the LifeBubble device in such populations requires additional research.

There are limitations to this study and the reported results. First, the study design was single center and retrospective, and the choice of securement method was not randomized, which introduces the possibility of bias into the results. The study reports pragmatic results based on current routine care, in which the control group uses a standard practice of adhering the UC to the abdomen. Both this adhesive method and the alternative tape in a goal post formation are considered standard practice for NICUs around the globe. An ideal study design would be both prospective and with randomization of the securement method. There was a significant difference in mean birth weight with a slightly higher birth weight in the LifeBubble group. The larger birth weight in the LifeBubble group may have had a tendency to reduce the rate of UC movement and malposition leading to discontinuation, but not enough to affect the significance of the reductions in the outcome measures of UVC movement and malposition leading to discontinuation and UAC discontinuation with LifeBubble securement compared to standard adhesive securement. Furthermore, this study does not address the meaningful group of premature neonates with birth weights <1000 g. While these patients are at risk for UC migration and infection complications, the LifeBubble product available at the time of the study was not used for extremely low birth weight patients due to its size.

To date, umbilical catheter migration has been largely viewed as an unavoidable and intrinsic disadvantage of these central catheters. Securement of umbilical catheters is a chronic problem and the current securement techniques need to be improved upon to reduce rates of UC malposition. A recent study evaluated the potential of using cyanoacrylate glue to reduce UVC dislodgement rates in the first 48 hours [32]. Solutions are evolving, and this study demonstrated one way for NICUs to decrease early UC discontinuation rates and improve resulting critical patient outcomes, through the adoption of a standardized, mechanical securement technique such as the LifeBubble device.