Trial Outcomes & Findings for Comparing Peripherally Inserted Central Catheters to Long Peripheral Catheters in Pediatrics (NCT NCT05346406)
NCT ID: NCT05346406
Last Updated: 2025-06-17
Results Overview
Percent eligible patients that agreed to participate in the randomized part of the study
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Day of enrollment
Results posted on
2025-06-17
Participant Flow
We had an enrollment goal of 30 participants per each randomized arm. The RCT eligibility was not met.
Participant milestones
| Measure |
Peripherally Inserted Central Catheter, Randomized (PICC R)
PICC Randomized arm:
An uncoated polyurethane PICC with an external clamp was placed in the upper arm, and the available sizes were 3 to 6Fr (Bard, Becton Dickinson). The catheter type and size were selected based on IR standard protocol.
|
Midline Catheter, Randomized (MC R)
MC Randomized arm:
An uncoated MC with available sizes of 8 cm, 20 to 22G (Powerglide, Becton Dickinson). The catheter size was selected by an inserter based on patient size. All MCs were placed in the upper arm with the tip of the catheter ending at or below the axilla
|
Peripherally Inserted Central Catheter, Non-randomized (PICC NR)
PICC non-randomized arm (observational only)
|
Midline Catheter, Non-randomized (MC NR)
MC non-randomized arm - observational only
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
6
|
21
|
|
Overall Study
COMPLETED
|
4
|
4
|
6
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Peripherally Inserted Central Catheters to Long Peripheral Catheters in Pediatrics
Baseline characteristics by cohort
| Measure |
Peripherally Inserted Central Catheter, Randomized (PICC R)
n=4 Participants
PICC randomized arm:
An uncoated polyurethane PICC with an external clamp was placed in the upper arm, and the available sizes were 3 to 6Fr (Bard, Becton Dickinson). The catheter type and size were selected based on IR standard protocol.
|
Midline Catheter, Randomized (MC R)
n=4 Participants
MC randomized arm:
An uncoated MC with available sizes of 8 cm, 20 to 22G (Powerglide, Becton Dickinson). The catheter size was selected by an inserter based on patient size. All MCs were placed in the upper arm with the tip of the catheter ending at or below the axilla
|
Peripherally Inserted Central Catheter, Non-randomized (PICC NR)
n=6 Participants
PICC non-randomized arm - observational only
|
Midline Catheter, Non-randomized (MC NR)
n=21 Participants
MC non-randomized arm -observational only
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
10.2 years
n=5 Participants
|
10.8 years
n=7 Participants
|
8.4 years
n=5 Participants
|
11.2 years
n=4 Participants
|
9.8 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Severity/Location
Acute care
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Severity/Location
Critical care
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Primary Diagnosis
Medical
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Primary Diagnosis
Surgical
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day of enrollmentPopulation: The primary outcome, a feasibility outcome, only applied to the randomized portion of the study (PICC R and MC R arms); and is the proportion of patients that agreed to participate in randomization out of all eligible patients. Therefore, the Overall Number of Participants Analyzed represents the number of participants eligible for the randomization part of the study prior to enrollment.
Percent eligible patients that agreed to participate in the randomized part of the study
Outcome measures
| Measure |
Eligible Participants
n=10 Participants
All participants eligible for the randomized portion of the study
|
Midline Catheter, Randomized (PICC R)
MC Randomized arm:
An uncoated MC with available sizes of 8 cm, 20 to 22G (Powerglide, Becton Dickinson). The catheter size was selected by an inserter based on patient size. All MCs were placed in the upper arm with the tip of the catheter ending at or below the axilla
|
Peripherally Inserted Central Catheter, Non-randomized (PICC NR)
PICC non-randomized arm (observational only)
|
Midline Catheter, Non-randomized (MC NR)
MC non-randomized arm - observational only
|
|---|---|---|---|---|
|
Percent Eligible Patients That Agreed to Participate
|
80 percentage of eligible patients agreed t
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: An average of 14 daysDwell-time will be measured using the time-to-device removal for all reasons (both secondary to completion of therapy and secondary to complications).
Outcome measures
| Measure |
Eligible Participants
n=4 Participants
All participants eligible for the randomized portion of the study
|
Midline Catheter, Randomized (PICC R)
n=4 Participants
MC Randomized arm:
An uncoated MC with available sizes of 8 cm, 20 to 22G (Powerglide, Becton Dickinson). The catheter size was selected by an inserter based on patient size. All MCs were placed in the upper arm with the tip of the catheter ending at or below the axilla
|
Peripherally Inserted Central Catheter, Non-randomized (PICC NR)
n=6 Participants
PICC non-randomized arm (observational only)
|
Midline Catheter, Non-randomized (MC NR)
n=21 Participants
MC non-randomized arm - observational only
|
|---|---|---|---|---|
|
Average Dwell-time
|
11.0 days
Interval 7.8 to 12.0
|
4.7 days
Interval 3.3 to 5.9
|
8.5 days
Interval 5.5 to 18.9
|
8.0 days
Interval 6.2 to 9.1
|
SECONDARY outcome
Timeframe: An average of 14 dayspercent of participants in each group that completed the therapy the VAD was requested for with original VAD
Outcome measures
| Measure |
Eligible Participants
n=4 Participants
All participants eligible for the randomized portion of the study
|
Midline Catheter, Randomized (PICC R)
n=4 Participants
MC Randomized arm:
An uncoated MC with available sizes of 8 cm, 20 to 22G (Powerglide, Becton Dickinson). The catheter size was selected by an inserter based on patient size. All MCs were placed in the upper arm with the tip of the catheter ending at or below the axilla
|
Peripherally Inserted Central Catheter, Non-randomized (PICC NR)
n=6 Participants
PICC non-randomized arm (observational only)
|
Midline Catheter, Non-randomized (MC NR)
n=21 Participants
MC non-randomized arm - observational only
|
|---|---|---|---|---|
|
Number of Participants Who Completed Therapy With Initial VAD
|
4 Participants
|
1 Participants
|
6 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: An average of 14 daysthe rate of any complications, including suspected VTE (ultrasound obtained), suspected CLABSI (blood culture obtained), confirmed VTE (ultrasound positive for clot), confirmed CLABSI (blood culture positive), dislodgement, occlusion, phlebitis, line dysfunction, infiltration, leaking
Outcome measures
| Measure |
Eligible Participants
n=4 Participants
All participants eligible for the randomized portion of the study
|
Midline Catheter, Randomized (PICC R)
n=4 Participants
MC Randomized arm:
An uncoated MC with available sizes of 8 cm, 20 to 22G (Powerglide, Becton Dickinson). The catheter size was selected by an inserter based on patient size. All MCs were placed in the upper arm with the tip of the catheter ending at or below the axilla
|
Peripherally Inserted Central Catheter, Non-randomized (PICC NR)
n=6 Participants
PICC non-randomized arm (observational only)
|
Midline Catheter, Non-randomized (MC NR)
n=21 Participants
MC non-randomized arm - observational only
|
|---|---|---|---|---|
|
Number of Participants With at Least One Complications
|
2 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 1 day (day of enrollment/VAD placement)sedation completed (yes/no)
Outcome measures
| Measure |
Eligible Participants
n=4 Participants
All participants eligible for the randomized portion of the study
|
Midline Catheter, Randomized (PICC R)
n=4 Participants
MC Randomized arm:
An uncoated MC with available sizes of 8 cm, 20 to 22G (Powerglide, Becton Dickinson). The catheter size was selected by an inserter based on patient size. All MCs were placed in the upper arm with the tip of the catheter ending at or below the axilla
|
Peripherally Inserted Central Catheter, Non-randomized (PICC NR)
n=6 Participants
PICC non-randomized arm (observational only)
|
Midline Catheter, Non-randomized (MC NR)
n=21 Participants
MC non-randomized arm - observational only
|
|---|---|---|---|---|
|
Number of Participants That Received Sedation for VAD Placement
|
4 Participants
|
3 Participants
|
5 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: An average of 14 daysat least one successful blood draw (yes/no)
Outcome measures
| Measure |
Eligible Participants
n=4 Participants
All participants eligible for the randomized portion of the study
|
Midline Catheter, Randomized (PICC R)
n=4 Participants
MC Randomized arm:
An uncoated MC with available sizes of 8 cm, 20 to 22G (Powerglide, Becton Dickinson). The catheter size was selected by an inserter based on patient size. All MCs were placed in the upper arm with the tip of the catheter ending at or below the axilla
|
Peripherally Inserted Central Catheter, Non-randomized (PICC NR)
n=6 Participants
PICC non-randomized arm (observational only)
|
Midline Catheter, Non-randomized (MC NR)
n=21 Participants
MC non-randomized arm - observational only
|
|---|---|---|---|---|
|
Number of Participants With VAD Successfully Used for Blood Draws
|
4 Participants
|
2 Participants
|
5 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: An average of 14 daysany additional VADs placed to complete therapy or supplement therapy
Outcome measures
| Measure |
Eligible Participants
n=4 Participants
All participants eligible for the randomized portion of the study
|
Midline Catheter, Randomized (PICC R)
n=4 Participants
MC Randomized arm:
An uncoated MC with available sizes of 8 cm, 20 to 22G (Powerglide, Becton Dickinson). The catheter size was selected by an inserter based on patient size. All MCs were placed in the upper arm with the tip of the catheter ending at or below the axilla
|
Peripherally Inserted Central Catheter, Non-randomized (PICC NR)
n=6 Participants
PICC non-randomized arm (observational only)
|
Midline Catheter, Non-randomized (MC NR)
n=21 Participants
MC non-randomized arm - observational only
|
|---|---|---|---|---|
|
Number of Participants Requiring Additional VADs to Complete Therapy
|
0 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
Adverse Events
PICC R
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MC R
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PICC NR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MC NR
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PICC R
n=4 participants at risk
PICC Randomized arm:
An uncoated polyurethane PICC with an external clamp was placed in the upper arm, and the available sizes were 3 to 6Fr (Bard, Becton Dickinson). The catheter type and size were selected based on IR standard protocol.
|
MC R
n=4 participants at risk
MC Randomized arm:
An uncoated MC with available sizes of 8 cm, 20 to 22G (Powerglide, Becton Dickinson). The catheter size was selected by an inserter based on patient size. All MCs were placed in the upper arm with the tip of the catheter ending at or below the axilla
|
PICC NR
n=6 participants at risk
PICC non-randomized arm (observational only)
|
MC NR
n=21 participants at risk
MC non-randomized arm - observational only
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Occlusion
|
0.00%
0/4 • Up to 1 month while catheter in place
We report catheter-related confirmed VTE (ultrasound results positive for clot at catheter site), confirmed CLABSI (defined using the National Healthcare Safety Network surveillance definition)
|
25.0%
1/4 • Up to 1 month while catheter in place
We report catheter-related confirmed VTE (ultrasound results positive for clot at catheter site), confirmed CLABSI (defined using the National Healthcare Safety Network surveillance definition)
|
0.00%
0/6 • Up to 1 month while catheter in place
We report catheter-related confirmed VTE (ultrasound results positive for clot at catheter site), confirmed CLABSI (defined using the National Healthcare Safety Network surveillance definition)
|
4.8%
1/21 • Up to 1 month while catheter in place
We report catheter-related confirmed VTE (ultrasound results positive for clot at catheter site), confirmed CLABSI (defined using the National Healthcare Safety Network surveillance definition)
|
|
Blood and lymphatic system disorders
Infiltration
|
0.00%
0/4 • Up to 1 month while catheter in place
We report catheter-related confirmed VTE (ultrasound results positive for clot at catheter site), confirmed CLABSI (defined using the National Healthcare Safety Network surveillance definition)
|
25.0%
1/4 • Up to 1 month while catheter in place
We report catheter-related confirmed VTE (ultrasound results positive for clot at catheter site), confirmed CLABSI (defined using the National Healthcare Safety Network surveillance definition)
|
0.00%
0/6 • Up to 1 month while catheter in place
We report catheter-related confirmed VTE (ultrasound results positive for clot at catheter site), confirmed CLABSI (defined using the National Healthcare Safety Network surveillance definition)
|
4.8%
1/21 • Up to 1 month while catheter in place
We report catheter-related confirmed VTE (ultrasound results positive for clot at catheter site), confirmed CLABSI (defined using the National Healthcare Safety Network surveillance definition)
|
|
Product Issues
Dislodgement
|
0.00%
0/4 • Up to 1 month while catheter in place
We report catheter-related confirmed VTE (ultrasound results positive for clot at catheter site), confirmed CLABSI (defined using the National Healthcare Safety Network surveillance definition)
|
0.00%
0/4 • Up to 1 month while catheter in place
We report catheter-related confirmed VTE (ultrasound results positive for clot at catheter site), confirmed CLABSI (defined using the National Healthcare Safety Network surveillance definition)
|
0.00%
0/6 • Up to 1 month while catheter in place
We report catheter-related confirmed VTE (ultrasound results positive for clot at catheter site), confirmed CLABSI (defined using the National Healthcare Safety Network surveillance definition)
|
9.5%
2/21 • Up to 1 month while catheter in place
We report catheter-related confirmed VTE (ultrasound results positive for clot at catheter site), confirmed CLABSI (defined using the National Healthcare Safety Network surveillance definition)
|
|
Injury, poisoning and procedural complications
Pain
|
0.00%
0/4 • Up to 1 month while catheter in place
We report catheter-related confirmed VTE (ultrasound results positive for clot at catheter site), confirmed CLABSI (defined using the National Healthcare Safety Network surveillance definition)
|
0.00%
0/4 • Up to 1 month while catheter in place
We report catheter-related confirmed VTE (ultrasound results positive for clot at catheter site), confirmed CLABSI (defined using the National Healthcare Safety Network surveillance definition)
|
0.00%
0/6 • Up to 1 month while catheter in place
We report catheter-related confirmed VTE (ultrasound results positive for clot at catheter site), confirmed CLABSI (defined using the National Healthcare Safety Network surveillance definition)
|
4.8%
1/21 • Up to 1 month while catheter in place
We report catheter-related confirmed VTE (ultrasound results positive for clot at catheter site), confirmed CLABSI (defined using the National Healthcare Safety Network surveillance definition)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place