Peripherally Inserted Central Catheter Insertion Site and Complication Rate in Neonates

NCT ID: NCT03474978

Last Updated: 2023-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-19

Study Completion Date

2025-12-31

Brief Summary

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This study examines whether there is an association between the PICC insertion site and the complications necessitating PICC removal in neonates admitted to neonatal intensive care unit.

Detailed Description

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Conditions

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Catheterization, Peripheral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Upper Extremity Insertion

Peripherally Inserted Central Venous Cather (PICC) inserted in upper extremity

Group Type EXPERIMENTAL

Peripherally Inserted Central Venous Cather (PICC)

Intervention Type DEVICE

Location of the PICC insertion will be randomized and compared

Lower Extremity Insertion

Peripherally Inserted Central Venous Cather (PICC) inserted in lower extremity

Group Type EXPERIMENTAL

Peripherally Inserted Central Venous Cather (PICC)

Intervention Type DEVICE

Location of the PICC insertion will be randomized and compared

Interventions

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Peripherally Inserted Central Venous Cather (PICC)

Location of the PICC insertion will be randomized and compared

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Neonates of all gestational ages admitted to Foothills Medical Centre and Alberta Children's Hospital Neonatal Intensive Care Unit (NICU)
2. Peripherally inserted central venous catheter (PICC) line insertion planned as part of NICU care
3. Venous access available in both upper(above umbilicus) and lower body

Exclusion Criteria

1. Local infection at potential site of insertion
2. Hemangioma, lymphangioma or malformations in the region of insertion
3. Major chromosomal anomalies
Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Amuchou Soraisham

Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amuchou Soraisham, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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Foothills Medical Centre

Calgary, Alberta, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Amuchou Soraisham, MD

Role: CONTACT

403-944-8101

Facility Contacts

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Amuchou Soraisham, MD, DM, FRCPC

Role: primary

403-944-8101

Harish Amin, MBBS, FRCPC

Role: backup

403-955-7513

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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REB17-2371

Identifier Type: -

Identifier Source: org_study_id

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