The ABBA project (Assess Better Before Access): a retrospective, cross-sectional study of neonatal intravascular device outcomes

doi:10.21203/rs.3.rs-1316137/v1

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The ABBA project (Assess Better Before Access): a retrospective, cross-sectional study of neonatal intravascular device outcomes

https://doi.org/10.21203/rs.3.rs-1316137/v1

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Background: Vascular access devices (VADs) play a vital role within the neonatal intensive care unit (NICU). However, VAD-use is not without significant risks, with complications such as infection, thrombosis, device occlusion and infiltration/extravasation frequently contributing to device-related failures and increase the risk of significant patient harm or injury.

Methods: A retrospective, cross-sectional, single-center study in a large 112-bed NICU in Qatar that routinely collected intravenous device data from January 2016 to December 2018 was evaluated. The outcome of interest was to identify and evaluate the relationships between unmodifiable and potentially modifiable factors and Assess the situation and patients Better Before initiating vascular Access (ABBA), potentially reducing unwarranted complication rates leading to therapy failure within the neonatal setting.

Results: During the study period, 23858 VADs were inserted. Of these, 89.3% were peripheral intravenous catheters (PIVCs). Infants who received a peripheral device were slightly older, with a median age of 8 (5) days, when compared to all infants receiving a central device, with a median age of 6 (4) days. Univariate logistic regression analyses identified 10 variables demonstrating significant relationships to device-related outcomes.

Conclusions: Four subgroups of VAD were identified (peripheral intravenous catheters, extended dwell-peripheral intravenous devices, peripherally inserted central catheters and umbilical venous catheters). Central vascular access (peripherally inserted central catheters and umbilical venous catheters) had the least reported complications. Future research toward improving patient and intravenous therapy-related outcomes plays an important role. It requires a focus on innovations and clinical advancements in the world of neonatology and vascular access devices.

Neonate

NICU

patient assessment

peripheral intravenous devices

central venous catheters

intravenous therapy

device-related complications

Vascular access devices play a vital role within the NICU. Optimum assessment for appropriate device choices are important factors for clinicians and patients who require safe and reliable intravenous therapies.

What is known about the subject?:

Ill newborns, especially preterm infants, are often dependent on various central venous access devices for administration of required therapies.

Complications occur frequently in this patient population and are generally well-defined, however reliable, and accurate clinical data is often missing.

What this study adds:

The importance of a structured VAD algorithm following the ‘5Rights’ for vascular access.

Central vascular access devices show lower complication rates when compared to peripheral vascular access devices in neonatal patients.

It is suggested that intravenous (IV) vascular access is the most commonly performed invasive procedure in clinical settings worldwide. [1] The support and management of neonatal patient conditions rely tremendously upon a provision of stable vascular access for the administration of required and essential fluids, medications, nutrition, and blood products. [2] Vascular access devices (VADs), either central or peripheral, play a vital role within the neonatal intensive care unit (NICU). However, VAD use is not without significant risks, with complications such as infections, thrombosis, device occlusion and peripheral intravenous infiltration/extravasation (PIVIE) frequently resulting in device failures and a potential but significant patient harm or injury. [3] Observational studies have found peripheral IV related complications as high as 75% [4, 5], and 0.05–3% of central catheters in neonates resulted in therapy-related complications and device failure. [6, 7]

Preterm and sick neonates have an increased risk of complications, primarily due to an immature immune system, underdeveloped skin barrier, smaller, fragile blood vessels and exposure to invasive diagnostic and therapeutic procedures. [2, 8, 9, 10] VAD choices, insertion techniques and management are complex and multi-faceted, as multiple interdisciplinary clinicians are frequently involved in their care. Evidence-based VAD insertion and maintenance strategies including appropriate skin/site antisepsis and dressings have been developed to reduce the preventable causes of VAD failure and complications, however evidence in the neonatal population is limited. [11, 12] Approaches to VAD selection, insertion and maintenance in neonates frequently vary among caregivers, with practice often based on traditional practices, anecdotal evidence or practices recommended for adults and adolescents. [8, 13, 14] Undertaking clinical research can help identify evidence-based practices that demonstrate effective methods for reducing preventable causes of patient harm or injury, providing recommendations and guidelines for healthcare practitioners to focus on providing better and safer solutions and outcomes.

Cross-referencing Pettit’s benchmark studies [6, 7] with recent literature shows the incidence of neonatal vascular access device-related complications has remained persistent over the recent decades, irrespective of newer clinical innovations and changes in practice. Infection rates are highly variable for both peripheral and central VAD but have been documented between 0.43 to 49 incidents/1000 catheter days. [15, 16, 17]

Currently, PIVCs are most frequently used to provide infusion therapy. [5, 18, 19, 20] It seems a presumption of high rates of central line-associated bloodstream infections (CLABSI) plays a significant role in making the, often inappropriate, choice of VADs. Comparison studies between CLABSI and peripheral line-associated bloodstream serious infections (PLABSI) are limited [16, 17, 21, 22, 23] and do not indicate any preference to either PIVC or PICC. A Cochrane review to determine the effects of infusion of parenteral nutrition via percutaneous central venous catheters versus peripheral cannulae concluded there was no evidence suggesting that percutaneous central venous catheter use increased risks of adverse events, particularly invasive infection. [24]

Extrinsic modifiable factors influence successes and failures, highlighting quality clinician training, established competencies, clinical experience, choices regarding device type, patient assessment and insertion techniques, including care and maintenance bundles, device stabilization and securement, and lastly dressing protocols. [3, 8, 25, 26] Recent evidence from larger scale studies in neonatal populations regarding factors influencing VADs is still lacking and largely absent. This study aims to identify and evaluate the relationships between unmodifiable and potentially modifiable factors and Assess the situation and patients Better Before initiating vascular Access (ABBA), potentially reducing unwarranted complication rates within the neonatal setting.

Design and setting

In this retrospective, cross-sectional, single center study, routinely collected anonymized intravenous device data from January 2016 to December 2018 was evaluated. The outcomes of interest were the occurrence of any complication in relation to the use of different type of utilized VAD, consequently leading to therapy failure and the unplanned removal of the device. The study was performed in a large NICU (112 beds) of the Women’s Wellness and Research Centre (WWRC) of Hamad Medical Corporation (HMC), Doha, Qatar. The study protocol (MRC-01-19-166) was approved by the above facility’s Institutional Review Board (IRB). As the data source was anonymized, the local IRB deemed that participant consent was not required and determined the study a ‘quality chart review’. This study aims to determine the prevalence of peripheral (PIVC, ED-PIVC) versus central (PICC, UVC) device-related failures and its associated complications (e.g., infection, occlusion, infiltration, and extravasation), evaluate VAD efficacy, identify any modifiable risk factors, as lastly, to drive innovation, evidence-based practices and policy development.

Patient and public involvement statement

Considering the retrospective design, study participants, nor parents were involved in the design, conduct or reporting of this study.

Participants and sample size

All neonates who were admitted to the NICU and required intravenous therapy through either a PIVC, ED-PIVC, PICC, or umbilical venous catheters (UVC) were included in the study. Participants were excluded from the study if data collection was incomplete or if data only related to the use of an arterial device e.g., umbilical or peripheral arterial catheters.

Procedure

In the facility, intravenous cannulation is routinely performed by the neonatal vascular access team (NeoVAT). The NeoVAT group is defined as a group of clinicians (nurses and doctors) whose primary role is for the assessment of IV access device need, insertion, oversight of care and use, the management of complications, and collection of vascular access device-related data [27, 28]. Two notable team delineations are the nurse-led team for peripheral (including Extended-Dwell Peripheral IV Catheters (ED-PIVC) venous access alone, and a more experienced mixed professional group providing all responsibility for CVADs. In the patient assessment stage, the team follows a locally developed mnemonic, the “5Rights for Vascular Access” i.e., the Right device, for the Right vein, with the Right therapy, for the Right duration, for the Right patient, as described in a similar concept by Steere et al. [29] [Figure 1].

Both peripheral and central venous cannulation are performed strictly under guidance of the local hospital policy and based on current international standards of practice. [30, 31] The selection of suitable veins is performed using near Infra-Red (nIR) technology for vein visualization, with the saphenous and antecubital veins generally being avoided for peripheral IV cannulation. In this facility’s practice, the choice of appropriate vascular access device is based upon the duration of required therapies, fluid characteristics (pH and osmolarity), patient characteristics, including body weight, and a known history of difficult intravascular access. The design of the vascular access device flowchart is based upon the current infusion standards of practice [30, 31] and local contexts such as product compatibility, hospital purchasing decisions and practitioner consensus.

Measurements and data collection

All patient demographics and baseline data included gender, gestational age at birth (in weeks and days), birth weight, and current body weight in grams. Data regarding the procedure for intravenous cannulation were date and time, the number of attempts needed to successful cannulation, cannulation laterality (left, right or middle), extremity and site/vessel on the extremity (e.g. dorsum of the hand, wrist or forearm, antecubital fossa and upper arm, foot, ankle and lower leg, or knee and upper leg), device type and size (PIVC, ED-PIVC, PICC, CVC, UVC), indication for intravenous treatment (intravenous fluids, medication therapy, total parenteral nutrition, blood and/or blood product administration, blood sampling, or procedural i.e. for power/contrast injection), date and time of device removal, total dwell time in hours (calculated as the removal date and time minus the insertion date and time), reason for removal (therapy completed/discontinuation of therapy warranting (elective) device removal, infiltration/extravasation (PIVIE), phlebitis, catheter related bloodstream infection (CRBSI), occlusion, dislodgement and accidental removal, discoloration, administrative censoring (patient transferred or expired).

Statistical Analyses

Descriptive statistics were used to summarize the outcomes with a mean and its standard deviation or median and an interquartile range for continuous variables regarding normal distribution, and absolute numbers with percentage for discrete variables. The assumption of normal distribution was proved with Kolmogorov-Smirnof testing. Differences regarding outcomes and measurements were demonstrated by using the χ²-test, Mann-Whitney U test or unpaired samples t-test, as appropriate. For analyses between study groups regarding the inserted vascular access device, one-way ANOVA testing was used with Bonferoni post-hoc analyses. Any relation between independent variables with the outcome of interest was identified using univariate logistic regression analysis. Variables with significance in the univariate analysis (P < .05) were used for multivariate logistic regression analyses. Using a backward elimination process based on the highest Wald score and lowest P value, the smallest set of factors with a significant relation which the occurrence of complications was identified. Odds ratio with its 95% confidence interval (CI) were identified in these analyses. Throughout this study, a P < 0.05 was denoted to be statistically significant. SPSS (Version 25.0; SPSS Inc., Chicago, IL, USA) was used for statistical analysis.

During the study period, authors recorded a total of 23858 vascular access devices (VAD) inserted during the study period. Of these, 21313 (89.3%) peripheral intravenous catheters (PIVC) were inserted, 689 (2.9%) were extended-dwell peripheral intravenous catheters (ED-PIVC), 1335 (5.6%) were peripherally inserted central catheters (PICC), and 521 (2.2%) umbilical venous catheters were inserted. Insertion of a VAD was successful in 21594 patients, resulting in a 90.5% overall success rate. Individual success rates were observed after insertion of PIVC (90.5%), ED-PIVC (92.5%), PICC (87.9%) and UVC (95.8%) respectively.

A summary of patient characteristics is shown in Table 1. Overall, there was equal distribution of patient’s gender across the type of devices inserted (P = .571, χ² = 4.788, df = 6). The mean gestational age at birth of the total cohort was 34.4 ± 4.8 weeks, the median age of the patients in days at the moment of insertion of the VAD was 2 (4) days. A higher number of preterm infants underwent CVAD placement (PICC or UVC), with a mean gestational age at birth of 30.4 ± 4.6 weeks, compared to infants who received a peripheral device (PIVC or ED-PIVC) with a mean gestational age of 34.7 ± 4.6 weeks (P < .001, t = 37.533, df = 23856). Patients who received a peripheral device were slightly older, with a median age of 8 (5) days, when compared to all infants receiving a CVAD, with a median age of 6 (4) days. This difference was not statistically significant (P = .940, U = 20397070, Z=-0.075). Regarding a patient’s weight at the time of VAD insertion, those who underwent insertion of a peripheral device had a mean weight of 2430 ± 928 grams and patients who received a CVAD had a mean weight of 1566 ± 923 grams (P < .001, t = 38.534, df = 23856), demonstrating statistical significance.

Table 1

**Demographics and baseline parameters**. Data are represented as absolute numbers (percentages).
		PIVC N = 21313	ED-PIVC N = 689	PICC N = 1335	UVC N = 521
Gender	Male Female Ambiguous	12117 (56.9%) 9174 (43.0%) 22 (01%)	389 (56.5%) 300 (43.5%) 0 (0%)	755 (56.6%) 580 (43.4%) 0 (0%)	280 (53.7%) 241 (46.3%) 0 (0%)
Gestational age at birth	< 28 weeks 28–31 weeks 32–36 weeks > 36 weeks	2643 (12.4%) 1600 (7.5%) 6489 (30.4%) 10581 (49.6%)	19 (2.8%) 49 (7.1%) 321 (46.6%) 300 (43.5%)	405 (30.3%) 412 (30.9%) 366 (27.4%) 152 (114%)	219 (42.0%) 60 (11.5%) 65 (12.5%) 177 (34.0%)
Weight at birth	< 1000 grams 1000–1499 grams 1500–2500 grams > 2500 grams	2557 (12.0%) 1752 (8.2%) 7305 (34.3%) 9699 (45.5%)	18 (2.6%) 25 (3.6%) 372 (54.0%) 274 (39.8%)	368 (27.6%) 528 (39.6%) 309 (23.1%) 130 (9.7%)	214 (41.1%) 58 (11.1%) 83 (15.9%) 166 (31.9%)
Age at insertion	< 28 weeks 28–31 weeks 32–36 weeks > 36 weeks	725 (3.4%) 1546 (7.3%) 7531 (35.3%) 11467 (53.8%)	0 (0%) 21 (3%) 338 (49.1%) 330 (47.9%)	298 (22.3%) 398 (29.8%) 422 (31.6%) 216 (16.2%)	218 (41.6%) 60 (11.5%) 64 (12.3%) 179 (34.4%)
Weight at insertion	< 1000 grams 1000–1499 grams 1500–2500 grams > 2500 grams	1161 (5.4%) 2251 (10.6%) 7983 (37.5%) 9918 (46.5%)	3 (0.4% 38 (5.5%) 374 (54.3%) 274 (39.8%)	354 (26.5%) 569 (42.6%) 257 (19.3%) 155 (11.6%)	220 (42.2%) 57 (10.9%) 82 (15.7%) 162 (31.1%)

Table 1.

The primary reason for VAD insertion was to provide continuous infusion for IV therapies and/or medication administration (91%). In general, a median of one (1) attempt was required to obtain successful vascular access. See Table 2.

Table 2

**Data related to insertion of the devices.** Data are represented as absolute numbers (percentages), mean ± standard deviation or median (range), as appropriate.
		PIVC N = 21313	ED-PIVC N = 689	PICC N = 1335	UVC N = 521
Indication for intravenous therapy	Procedure: IV therapy/ medications Fluid characteristics Patient characteristics Blood extraction	318 (1.5%) 19495 (91.5%) 0 (0%) 0 (0%) 1500 (7%)	0 (0%) 689 (100%) 0 (0%) 0 (0%) 0 (0%)	0 (0%) 1147 (85.9%) 65 (4.9%) 123 (9.2%) 0 (0%)	0 (0%) 343 (65.8%) 89 (17.1%) 89 (17.1%) 0 (0%)
Insertion side	Left Right Midline	11816 (55.4%) 9492 (44.5%) 5 (0.1%)	434 (63%) 255 (37%) 0 (0%)	402 (30.1%) 933 (69.9%) 0 (0%)	0 (0%) 0 (0%) 521 (100%)
Insertion site on the body	Ankle Elbow Foot Hand Knee Lower arm Lower leg Scalp Upper arm Upper leg Wrist Umbilicus	13 (0.1%) 20 (0.1%) 2448 (11.5%) 18083 84.8%) 0 (0%) 582 (2.7%) 27 (0.1%) 5 (< 0.1%) 23 (0.1%) 6 (< 0.1%) 106 (0.5%) 0 (0%)	12 (1.7%) 3 (0.4%) 415 (60.2%) 58 (8.4%) 10 (1.5%) 53 (7.7%) 64 (9.3%) 0 (0%) 12 (1.7%) 61 (8.9%) 1 (0.1%) 0 (0%)	1030 (77.2%) 248 (18.6%) 0 (0%) 0 (0%) 37 (2.8%) 0 (0%) 10 (07%) 0 (0%) 7 (0.5%) 3 (02%) 0 (0%) 0 (0%)	0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 521 (100%)
Number of attempts to cannulation success		1.4 ± 0.7	1.4 ± 0.7	1.4 ± 0.7	1.0 (0.0)
Successful cannulation	Yes	19284 (90.5%)	637 (92.5%)	1174 (87.9%)	499 (95.8%)

Table 2.

Data regarding VAD removal is presented in Table 3. In 41% of cases, the VAD was removed after successful completion of therapy. A complication which may have led to premature VAD removal occurred in 48% of all cases. The study showed an overall complication incidence rate of 260/1000 catheter days. The incidence rate was highest in patient who got a PIVC inserted (411/1000 catheter days), the lowest complication rate was registered after insertion of a PICC (10/1000 catheter days). After insertion of a peripheral device, a complication occurred in 11177 (51%) patients, of which occurred only in 221 (12%) patients where a CVAD was inserted (P < .001, χ² = 1037.675, df = 1). In general, patients who received a peripheral catheter, the complication rate was significantly higher when compared to infants receiving a CVAD (407/1000 catheter days and 13/1000 catheter days respectively).

Table 3

**Data related to removal of the devices**. Data are represented as absolute numbers (percentages) or mean ± standard deviation, as appropriate.
		PIVC N = 19284	ED-PIVC N = 637	PICC N = 1174	UVC N = 499
Reason for removal	Therapy success:	8318 (43.1%)	197 (30.9%)	903 (76.9%)	329 (65.9%)
	Therapy failure: PIVIE Leaking Phlebitis Discoloration Suspected sepsis Catheter related complication Maintenance related complication	10747 (55.7%) 5347 (49.7%) 2263 (21.0%) 1711 (15.9%) 44 (0.4%) 1 (0.009%) 0 (0%) 1381 (12.85%)	430 (67.5%) 210 (48.8%) 52 (12.1%) 138 (32.1%) 2 (0.46%) 0 (0%) 0 (0%) 28 (6.5%)	137 (11.7%) 0 (0%) 0 (0%) 7 (5.1%) 0 (0%) 31 (21.9%) 63 (45.9%) 37 (27.0%)	83 (16.6%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 3 (3.6%) 64 (77.1%) 16 (19.2%)
	Administrative censoring	225 (1.1%)	10 (1.6%)	133 (11.2%)	87 (17.4%)
Dwell time	Hours	32.6 ± 22.3	48.7 ± 36.8	280.8 ± 184.5	132.8 ± 135.6

Table 3.

An incidence rate of CRBSI was 1.19/1000 catheter days was observed for all peripheral intravenous access devices (PIVC and ED-PIVC), whereas an incidence rate of 0.34/1000 catheter days was observed after CVAD insertion (P < .001, t = 8.985, df = 21583) (See Fig. 2).

FIGURE 2.

An overall mean dwell time of 49 ± 78 hours was recorded throughout the total cohort of included patients. Peripheral device dwell times were significantly lower when compared to CVADs (P < .001, t = 143.595, df = 21583), with dwell times of 22 ± 23 and 236 ± 183 hours respectively. Catheter dwell times differed between the type of devices inserted, as shown in Fig. 3 (P < .001, Log-rank χ² = 2728.135, df = 3).

FIGURE 3.

Univariate logistic regression analyses identified 10 variables demonstrating significant relationships to the outcomes of interest: patient gender, gestational age at birth, age at device insertion, weight at birth, weight at device insertion, indication for intravenous therapy, type of VAD inserted, chosen site of insertion, successful insertion on first attempt, and dwell time of the device. These variables were all entered for multivariate logistic regression analysis, of which 4 had a significant relationship with outcomes: the type of device inserted (P < .001, OR = 0.40, 95%-CI 0.33–0.48), reason/indication for intravenous therapy (P < .001, OR = 0.79, 95%-CI 0.76–0.82), dwell time of the device [in days] (P < .001, OR = 0.80, 95%-CI 0.78–0.82), and weight of the patient at insertion of the device (P < .001, OR = 0.81, 95%-CI 0.76–0.86).

Neonates are an extremely vulnerable patient population. Vascular access devices provide the mainstay of all parenterally administered therapies for these, often high-risk, patients. The incidence of VAD therapy failure may negatively impact clinical therapies and outcomes which are dependent on appropriate, safe, and reliable vascular access. Carr et al. [32] determined failure of VADs, resulting in premature device removal, occurred in 48% of participants, with a complication incidence rate of 260/1000 device days. The most frequently reported failure of therapy was in the PIVC group (411/1000 catheter days) and the least frequent in the PICC group (10/1000 catheter days). The risk of therapy failure had 4 significant variables: the type of VAD, reason or indication for intravenous therapy, dwell time of the VAD (in days), and weight of the patient at insertion of the VAD.

While this study provides recent clinical evidence on various risks of therapy failure with intravenous devices in neonates, it has also been reported in previous publications. [2, 5, 33] To the best of the authors knowledge, a study of this sample size including both peripheral and central catheters, with focus on device-related failures in neonates, has not been previously published.

To obtain vascular access during hospitalisation, PIVCs are often sourced as the primary and most inserted devices. [5] The incidence of PIVC therapy failure from this study demonstrates a slightly higher rate when compared with the pooled rates of failure (34%) in a recently published meta-analyses. [33] However, the incidence parallels other recently published unit-based research. [5] It is difficult to give an unambiguous clarification for this, although the pattern of complications and their relative incidences do correlate.

Results from a small retrospective study performed in a level III NICU, stated that use of an extended dwell peripheral intravenous catheter (ED-PIVC) may be a useful option in providing vascular access choices and reduced costs in NICU patients. [8] This research compared complications of PICC, ED-PIVC and PIVC, and when compared to standard PIVCs alone, ED-PIVCs demonstrated advantages in overall device dwell time (ranging 1–29 days), despite that 28.3% of devices were removed before the completion of therapy. ED-PIVCs also indicated a lower rate of infiltration/extravasation-related episodes when compared to standard PIVCs (1.2% v’s 3.9%). The authors concluded at ED-PIVCs offer significant benefits over standard PIVC and moderate financial savings when compared to PICC use and frequent PIVC replacement.

In this current study, the use of a PICC reported the least therapy failures and longest dwell times. In the study by Chenoweth et al., PICCs had similar success rates compared to peripheral catheters (PIVC and ED-PIVC), when regarding the completion of therapy (P = 0.001). [8] Another recent study evaluated the clinical efficacy and safety of ultrasound-guided, subcutaneously tunneled, femorally-inserted PICC in the NICU. [34] No insertion-related or post-insertion complications were reported, and all patients completed prescribed therapy with one catheter. [34]

In most NICUs, UVCs are not used for more than 5–7 days, due to increased incidence of late-onset sepsis (LOS) related to UVC longevity. A previous study by Konstantinidi et al. shows the incidence of complications associated with the use of UVCs and PICCs do not significantly differ. [35] This current research also confirms these results and shows PICCs have the benefits of the longest extended dwell times and lowest incidence of related therapy failures.

Strength and limitations

To the authors’ understanding, this is the first and largest study of this kind to examine the use of VADs and effect on therapy failures in the neonatal population in this geographical region. All eligible neonates were included, and the sample size was large and representative of the neonatal population requiring VADs. This increased the statistical power of the study’s findings, helping to minimize selection bias and increase the generalizability of the findings to similar settings.

Despite these strengths, there are limitations to this research. This study was a single center, retrospectively collected dataset, and in contrast to randomized studies, this method creates risk for selection bias. For this study, every infant with a successfully inserted PICC was included to minimize the risk of selection bias. Interrater variability may have affected the results; however, the facility’s use of a standardized education program and limiting vascular access procedures to members of a dedicated vascular access team (neoVAT) may have helped reduce data variability. Data outcomes that were not available for neonates (death or were transferred out of the facility) were deemed as ‘administrative censoring’ (in Table 3). Although this population was relatively small, patients lost to follow-up may have a differing outcome than those who completed the study. Nonetheless, future research should focus on the introduction of new and clinically beneficial strategies to help improve successful therapy outcomes no matter the type of VAD.

In general, many patients experienced a vascular access-related complication, resulting in therapy failure. Several variables demonstrated benefit from the use of a PICC as VAD, impacting infusion therapy and resulting in successful completion of the prescribed infusion therapy for patients admitted to the NICU.

Four different types of VADs (PIVC, ED-PIVC, PICC and UVC) were identified, divided in two groups (central and peripheral), each device with unique characteristics affecting therapy and dwell time in patients admitted to the NICU. Four variables had a significant relationship with therapy failure. Weight (birth- and current weight), cannulation site, type of device, and the indication for intravenous treatment all affected the risk for failure. This current study demonstrates the highest complication rates were amongst the peripheral vascular access devices when compared to CVADs, including catheter-related bloodstream infections (CRBSI). The risk for the development of a VAD-related complication, leading to premature removal of the device, increased with extended dwell times. It seems that when a VAD is inserted, it is of utmost importance for the clinician to choose the optimum device for the patient and their required therapy. The most frequently observed therapy failure in this neonatal population was with the standard peripheral VAD group. Consequently, the authors agree that peripheral VADs should be used judiciously, and careful thought should be given prior to their use, particularly when there are alternate means of central access devices that may be utilized more appropriately.

Innovations and clinical advancements in the world of neonatology and vascular access devices with the least chance for therapy failure, play an important role toward improving patient and therapy-related outcomes. The optimum choice for the best available vascular device is an important step for clinicians who place and care for VADs, as well as for patients depending on reliable vascular access device for their required therapy. To Assess Better Before Access, development, and use of a VAD algorithm together with the 5Rights for vascular access may provide additional benefits in NICU’s.

VAD, Vascular access devices; NICU, Neonatal Intensive Care Unit; ABBA, Assess Better Before Access; PIVC, Peripheral Intra Venous Catheters; ED-PIVC, Extended Dwell-Peripheral Intra Venous Catheters; PICC, Peripherally Inserted Central Catheters; UVC, Umbilical Venous Catheters; IV, IntraVenous; PIVIE, Peripheral Intravenous Infiltration/Extravasation; IRB, Institution Review Body; CRBSI, Catheter Related Blood Stream Infection; CVAD, Central Venous Access Device; CLABSI, Central Line-Associated Blood Stream Infections; PLABSI, Peripheral Line-Associated Blood Stream Infections

i) Ethics approval and consent to participate

The study protocol (MRC-01-19-166) was approved by the Institutional Review Board (IRB) of the Women’s Wellness and Research Center, Hamad Medical Corporation. All methods were carried out in accordance with relevant guidelines and regulations.

As the data source was anonymized, the Ethics Committee/IRB deemed that participant consent was not required and determined the study a ‘quality review’. Study participants and parents were not involved in the design, conduct or reporting of this study. The local IRB made funds available to support any Open Access publication of this article after acceptance.

ii) Consent for publication

Consent was not required or applicable (see above).

iii) Availability of Data and Material (ADM)

The data that support the findings of this study are available from Matheus van Rens but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of Matheus van Rens ([email protected]).

iv) Competing interests

All contributing authors declare no financial disclosures, conflicts, or competing interests in the development of this research.

v) Funding

No industry funding, grants or sponsorship was received in the development of this research from any public, commercial or not-for-profit sectors for this research.

vi) Authors' contributions

Matheus F.P.T. van Rens was the main investigator, conceptualized and designed the study, coordinated, and supervised data collection, drafted the initial manuscript, and reviewed and revised the subsequent manuscript versions.

Mohammad A.A. Bayoumi, Agnes van de Hoogen, and Timothy R. Spencer. provided critical review and edited the manuscript for important intellectual, statistical, and academic content.

Airene L.V. Francia and Irian J. Cabanillas designed the data collection instruments, collected data, and reviewed and revised the manuscript.

Fredericus H.J. van Loon carried out statistical analyses, and critically reviewed the manuscript for important intellectual content and revised the manuscript.

All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

vii) Acknowledgment.

The authors would like to acknowledge all members of the neoVAT, Binsy Padinharayil and the nursing and medical staff of the NICU at WWRC for their support during the study period.

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The ABBA project (Assess Better Before Access): a retrospective, cross-sectional study of neonatal intravascular device outcomes

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