Comparing Peripherally Inserted Central Catheters to Long Peripheral Catheters in Pediatrics

NCT05346406 | Completed Results FDA Device

• 1 other identifier: MCW2022
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Peripherally Inserted Central Catheters (PICCs) are frequently used in hospitalized children who require prolonged vascular access; however, concerns regarding their inappropriate use and contribution to serious complications such as central line associated blood stream infection (CLABSI) and venous thromboembolism (VTE) have triggered exploration of safer alternatives. Long Peripheral Catheters (LPCs) have been recently adopted by some institutions due to fewer complications as compared to PICCs. The investigators hypothesize that LPCs could be safer alternatives to PICCs for medium-term vascular access (5-14 days) in the appropriate cohort of hospitalized pediatric patients. The primary objective of the proposed clinical effectiveness pilot trial is to test the feasibility of a full-scale effectiveness trial comparing PICCs to LPCs in hospitalized pediatric patients. The investigators aim to identify a population in which LPCs are safe and effective alternatives to PICCs for medium-term, non-central vascular access; data that will inform the design of a full-scale effectiveness study. The investigators plan to engage patients and families as advisors in vascular access device selection by understanding their experience with vascular access device placement and maintenance. Over time, use of LPCs should result in decreased inappropriate PICC utilization with a concomitant decrease in serious complications such as CLABSI and VTE.

Conditions

Vascular Access Device Complications

Keywords

peripherally inserted central catheters, long peripheral catheters

Outcome Measures

Primary Outcomes (2)

• Percent Eligible Patients That Agreed to Participate

  Percent eligible patients that agreed to participate in the randomized part of the study

  Day of enrollment

• Average Dwell-time

  Dwell-time will be measured using the time-to-device removal for all reasons (both secondary to completion of therapy and secondary to complications).

  An average of 14 days

Secondary Outcomes (5)

• Number of Participants Who Completed Therapy With Initial VAD

  An average of 14 days

• Number of Participants With at Least One Complications

  An average of 14 days

• Number of Participants That Received Sedation for VAD Placement

  1 day (day of enrollment/VAD placement)

• Number of Participants With VAD Successfully Used for Blood Draws

  An average of 14 days

• Number of Participants Requiring Additional VADs to Complete Therapy

  An average of 14 days

Study Arms (4)

Peripherally Inserted Central Catheter, Randomized (PICC R)

ACTIVE COMPARATOR

Device: Peripherally Inserted Central Catheter

Midline Catheter, Randomized (MC R)

EXPERIMENTAL

Also known as long peripheral catheter (LPC)

Device: Midline Catheter

Peripherally Inserted Central Catheter, Non-randomized (PICC NR)

NO INTERVENTION

Observational only arm

Midline Catheter, Non-Randomized (MC NR)

NO INTERVENTION

Observational only arm

Interventions

Midline Catheter DEVICE

Bard Powerglide 8 cm midline catheter

Also known as: Long peripheral catheter

Midline Catheter, Randomized (MC R)

Peripherally Inserted Central Catheter DEVICE

Bard 3fr, 4fr or 6fr; Cook 4fr; or Medcomp 1.9fr and 2.6fr

Peripherally Inserted Central Catheter, Randomized (PICC R)

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patients age 2 to 17 years admitted to Children's Wisconsin and requesting placement of a PICC for:
• anticipated length of intravenous treatment of 5-14 days AND
• peripherally compatible infusate AND
• VAD not needed at discharge

You may not qualify if:

• non-English-speaking family
• active bacteremia or VTE at site where device would be placed
• urgent need of vascular access (within 4 hours)

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Children's Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (12)

• Paterson RS, Chopra V, Brown E, Kleidon TM, Cooke M, Rickard CM, Bernstein SJ, Ullman AJ. Selection and Insertion of Vascular Access Devices in Pediatrics: A Systematic Review. Pediatrics. 2020 Jun;145(Suppl 3):S243-S268. doi: 10.1542/peds.2019-3474H.

  PMID: 32482738 BACKGROUND

• Ullman AJ, Marsh N, Mihala G, Cooke M, Rickard CM. Complications of Central Venous Access Devices: A Systematic Review. Pediatrics. 2015 Nov;136(5):e1331-44. doi: 10.1542/peds.2015-1507. Epub 2015 Oct 12.

  PMID: 26459655 BACKGROUND

• Ullman AJ, Bernstein SJ, Brown E, Aiyagari R, Doellman D, Faustino EVS, Gore B, Jacobs JP, Jaffray J, Kleidon T, Mahajan PV, McBride CA, Morton K, Pitts S, Prentice E, Rivard DC, Shaughnessy E, Stranz M, Wolf J, Cooper DS, Cooke M, Rickard CM, Chopra V. The Michigan Appropriateness Guide for Intravenous Catheters in Pediatrics: miniMAGIC. Pediatrics. 2020 Jun;145(Suppl 3):S269-S284. doi: 10.1542/peds.2019-3474I.

  PMID: 32482739 BACKGROUND

• Gibson C, Connolly BL, Moineddin R, Mahant S, Filipescu D, Amaral JG. Peripherally inserted central catheters: use at a tertiary care pediatric center. J Vasc Interv Radiol. 2013 Sep;24(9):1323-31. doi: 10.1016/j.jvir.2013.04.010. Epub 2013 Jul 19.

  PMID: 23876551 BACKGROUND

• Burek AG, Parker J, Bentzien R, Talbert L, Havas M, Hanson SJ. The Development of a Long Peripheral Catheter Program at a Large Pediatric Academic Center: A Pilot Study. Hosp Pediatr. 2020 Oct;10(10):897-901. doi: 10.1542/hpeds.2020-0181.

  PMID: 32998934 BACKGROUND

• Noonan PJ, Hanson SJ, Simpson PM, Dasgupta M, Petersen TL. Comparison of Complication Rates of Central Venous Catheters Versus Peripherally Inserted Central Venous Catheters in Pediatric Patients. Pediatr Crit Care Med. 2018 Dec;19(12):1097-1105. doi: 10.1097/PCC.0000000000001707.

  PMID: 30142121 BACKGROUND

• Xu T, Kingsley L, DiNucci S, Messer G, Jeong JH, Morgan B, Shutt K, Yassin MH. Safety and utilization of peripherally inserted central catheters versus midline catheters at a large academic medical center. Am J Infect Control. 2016 Dec 1;44(12):1458-1461. doi: 10.1016/j.ajic.2016.09.010.

  PMID: 27908432 BACKGROUND

• Chenoweth KB, Guo JW, Chan B. The Extended Dwell Peripheral Intravenous Catheter Is an Alternative Method of NICU Intravenous Access. Adv Neonatal Care. 2018 Aug;18(4):295-301. doi: 10.1097/ANC.0000000000000515.

  PMID: 29847401 BACKGROUND

• Kleidon TM, Schults JA, Wainwright C, Mihala G, Gibson V, Saiyed M, Byrnes J, Cattanach P, Macfarlane F, Graham N, Shevill E, Ullman AJ. Comparison of midline catheters and peripherally inserted central catheters to reduce the need for general anesthesia in children with respiratory disease: A feasibility randomized controlled trial. Paediatr Anaesth. 2021 Sep;31(9):985-995. doi: 10.1111/pan.14229. Epub 2021 Jun 21.

  PMID: 34053159 BACKGROUND

• Qian SY, Horn MT, Barnes R, Armstrong D. The use of 8-cm 22G Seldinger catheters for intravenous access in children with cystic fibrosis. J Vasc Access. 2014 Sep-Oct;15(5):415-7. doi: 10.5301/jva.5000274. Epub 2014 Jul 4.

  PMID: 25041922 BACKGROUND

• Pacilli M, Bradshaw CJ, Clarke SA. Use of 8-cm 22G-long peripheral cannulas in pediatric patients. J Vasc Access. 2018 Sep;19(5):496-500. doi: 10.1177/1129729818761278. Epub 2018 Mar 12.

  PMID: 29529968 BACKGROUND

• Paladini A, Chiaretti A, Sellasie KW, Pittiruti M, Vento G. Ultrasound-guided placement of long peripheral cannulas in children over the age of 10 years admitted to the emergency department: a pilot study. BMJ Paediatr Open. 2018 Mar 28;2(1):e000244. doi: 10.1136/bmjpo-2017-000244. eCollection 2018.

  PMID: 29637197 BACKGROUND

MeSH Terms

Interventions

Catheterization, Peripheral

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Results Point of Contact

• Title: Alina G Burek MD
• Organization: Medical College of Wisconsin

aburek@mcw.edu

414-337-7050

Study Officials

• Alina Burek

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 26, 2022
• Study Start: August 10, 2022
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: June 17, 2025
• Results First Posted: June 17, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)