Skip to content

A study for effectiveness of fixation method with new peripheral venous cannula fixation tape in newborns

A single-arm clinical trial to evaluate the effectiveness of peripheral venous line fixation using a prototype of a new intravenous cannula fixation tape in newborns

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032220168
Enrollment
60
Registered
2022-06-28
Start date
2022-06-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborn baby (GA > 32 weeks and BW > 1500g) who has secured a peripheral venous route at NICU

Interventions

Secure the peripheral venous route with new peripheral venous route fixation tape

Sponsors

Tsukamoto Keiko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A case of being hospitalized in the NICU and securing a peripheral venous route

Exclusion criteria

Exclusion criteria: Gestational age less than 32 weeks or birth weight less than 1500 g Serious skin disease

Design outcomes

Primary

MeasureTime frame
Percentage not removed 48 hours after securing peripheral venous route. Event-Free-Survival rate when time to secure the peripheral venous route is staring point, extraction due to leakage of the peripheral venous route or accidental removal, whichever comes first is the event, and scheduled removal of the peripheral venous route is the terminated halfway.)

Secondary

MeasureTime frame
Percentage of removal due to leakage Percentage of removal due to accident Percentage of planned removal Percentage of cancellations due to tape peeling Percentage of tape use termination due to skin abnormalities Incidence of skin abnormalities (redness, swelling, skin peeling, induration, etc.) Incidence of phlebitis, cellulitis, and calcification Adverse event rate

Contacts

Public ContactKeiko Tsukamoto

National Center for Child Health and Development

tsukamoto-k@ncchd.go.jp+81-3-3416-0181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026