CompletedNot Applicable

Comparing Ultrasound Guided PICC Line Insertion in Neonates With Standard Procedure

Canada60 participantsStarted 2016-07

Plain-language summary

This is a randomized controlled study comparing US guided vs standard procedure for PICC line placement in newborns admitted to Children's Hospital of Eastern Ontario Neonatal Intensive Care Unit who require a PICC line. Patients will be randomized using REDCap randomization module (stratified by gestational age \< 28 weeks and \>= 28 weeks and blocked to ensure approximate balance with each stratum) into two arms. - Arm 1: PICC line insertion procedure using anatomical landmarks and tip placement will be confirmed by X-ray (current standard); Arm 2: US guided PICC line insertion procedure and tip placement confirmation by both US and X-ray. Sample size of 33 infants per group would achieve greater than 80% power to detect a difference between groups. Primary outcome: Time to complete the standard versus the US-guided procedure. Secondary outcomes (comparison between two arms): The number of total "venipuncture" attempts needed to place a PICC line Number of tip manipulations after complete insertion Proportion of successful tip placement

Who can participate

Age range

1 Day – 28 Days

Sex

ALL

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: All newborns (0-28 days) admitted to Neonatal Intensive Care Unit who require PICC line insertion after consent has been obtained to include in this study. Including: * Infants who need prolonged Total Parenteral Nutrition requirement of \> 7 days. * Infants with difficult peripheral venous access who requires a central line * Infants who require IV medications for \> 7 days. * Infants who require medications given by central IV access * Infants who will undergo complex surgical procedures and will require central IV access before procedure. Exclusion Criteria: * Infants requiring isolation according to infection control protocols * Unable to obtain or refused consent for PICC line and/or study enrolment * Infants with any clinical contraindication for PICC line insertion as per unit policy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to complete the standard versus the US-guided procedure

Timeframe: one year

Trial details

NCT IDNCT02584530

SponsorChildren's Hospital of Eastern Ontario

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-30

View on ClinicalTrials.gov More Ultrasonography, Interventional trials