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Comparing Ultrasound Guided PICC Line Insertion in Neonates With Standard Procedure

NCT02584530 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-07-30

No results posted yet for this study

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

Conditions

  • Ultrasonography, Interventional
  • Peripheral Venous Catheterization

Interventions

PROCEDURE

Ultrasound guidance for PICC line placement

Apply ultrasound guidance for PICC line placement and positioning in newborns

Sponsors & Collaborators

  • Children's Hospital of Eastern Ontario

    lead OTHER

Principal Investigators

  • Nadya Ben Fadel, MD · Children's Hospital of Eastern Ontario

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2020-03-30
Completion
2020-03-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02584530 on ClinicalTrials.gov