TerminatedNot Applicable

NICU-TECH RM9L-RS Probe ME Feasibility Study

Stopped: Images not adequate to visualize catheter penetration or obtain measurements

United States31 participantsStarted 2010-06

Plain-language summary

Use of a new ultrasound device designed for babies to look at the catheters in veins and arteries as well as the blood vessel itself. An observational study to assess the the clinicians perception of the ultrasound image quality as a tool to detect catheters in vessels.

Who can participate

Age range23 Weeks – 6 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Neonates that are 23 gestational weeks at birth (and greater than 500 grams) to a 6 month old born infant at term (maximum weight 7 kg) who already have one or more lines placed (PIV/PAC/UVC/UACs/PICC) as part of their medical care. NO INFANT WILL HAVE A LINE PLACE FOR THE PURPOSE OF THIS STUDY Exclusion Criteria: * Neonates that are less than 23 gestational weeks at birth * Neonates that are 23 gestational weeks at birth but are less than 500 grams in weight * Patients weighing more than 7 kg.-Patients older than 6 months

What they're measuring

Participants That Fulfilled All Study Procedures.

Timeframe: 1 day (day of procedure)

Vessel Penetration of NICU-Tech RM9L-RS Probe

Timeframe: 1 day (day of procedure)

Trial details

NCT IDNCT01181596

SponsorGE Healthcare

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2011-11

Results submitted2013-08-27

View on ClinicalTrials.gov More Neonates trials