Optical Detection Infiltration/Extravasation in Neonates (ODINE)

NACompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 1, 2021

Primary Completion Date

May 5, 2022

Study Completion Date

July 12, 2022

Conditions
Extravasation InjuryInfant, Premature, Diseases
Interventions
DEVICE

ivWatch

The second half sample size PIVC will be enrolled into an alarming group. ivWatch will monitor the PIVC insertion site collecting data and sending visual and auditory notifications of any infiltration. The goals of the study on the alarming group are: a) to estimate the notification rate (the number of detected infiltration in the studied period; b) to evaluate the extension and severity of the detected infiltration at the time of the notification, so to gather if ivWatch is helpful in early diagnosis

Trial Locations (1)

00168

FPGemelliIRCCS, Rome

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

NCT05638971 - Optical Detection Infiltration/Extravasation in Neonates (ODINE) | Biotech Hunter | Biotech Hunter