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

JRCT ID: jRCTs032220168

Registered date:28/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Newborn baby (GA > 32 weeks and BW > 1500g) who has secured a peripheral venous route at NICU
• Date of first enrollment: 28/06/2022
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Secure the peripheral venous route with new peripheral venous route fixation tape

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >=
• Age maximum: < 1weeks old
• Gender: Both
• Include criteria: A case of being hospitalized in the NICU and securing a peripheral venous route

Exclude criteria

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

Related Information

• Primary Sponsor: Tsukamoto Keiko
• Source(s) of Monetary Support: ALCARE Co., Ltd.