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Clinical Practice Guideline for Neonatal Extravasation Injury

Primary Purpose

Extravasation Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clinical practice guideline for prevention and management of extravasation injury
Sponsored by
United Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extravasation Injury focused on measuring Intravenous nursing, Newborn infant, Neonatal intensive care units, Evidence-based professional practice

Eligibility Criteria

undefined - 1 Year (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Neonates who were admitted for intravenous medication or infusion therapy, and
  • Neonates whose parents were equal to or over 18 years old and able to communicate in Chinese or English.

Exclusion Criteria:

  • Neonates who were born with congenital dermatological problems such as ichthyosis and epidermolysis bullosa.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Clinical practice guideline (CPG) group

    Usual care group

    Arm Description

    Implementation of an evidence-based clinical practice guideline and delivery of an educational programme

    Usual care

    Outcomes

    Primary Outcome Measures

    Change in rate of peripheral intravenous extravasation
    The number of the incidents divided by the total number of catheter days and multiplied by 1,000
    Change in rate of extravasation from a central line
    The number of the incidents divided by the total number of catheter days and multiplied by 1,000

    Secondary Outcome Measures

    Change in nurses' level of knowledge
    The Neonatal Extravasation Knowledge Test
    Change in nurses' adherence to clinical practice guidelines
    A 27-item audit tool

    Full Information

    First Posted
    March 20, 2020
    Last Updated
    March 23, 2020
    Sponsor
    United Christian Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04321447
    Brief Title
    Clinical Practice Guideline for Neonatal Extravasation Injury
    Official Title
    Clinical Practice Guideline on the Prevention and Management of Neonatal Extravasation Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 14, 2015 (Actual)
    Primary Completion Date
    November 23, 2016 (Actual)
    Study Completion Date
    August 29, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    United Christian Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is aimed to evaluate the effectiveness of an evidence-based clinical practice guideline in the prevention and management of neonatal extravasation injury, and to examine the change in nurses' knowledge of and adherence to the guideline.
    Detailed Description
    A study with controlled before-and-after design was conducted. The clinical practice guideline was developed and a multifaceted educational program was delivered for nurses. Neonatal outcomes were collected at baseline and after completion of the intervention. The changes in nurses' level of knowledge and adherence to the guideline were also measured.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Extravasation Injury
    Keywords
    Intravenous nursing, Newborn infant, Neonatal intensive care units, Evidence-based professional practice

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    213 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Clinical practice guideline (CPG) group
    Arm Type
    Experimental
    Arm Description
    Implementation of an evidence-based clinical practice guideline and delivery of an educational programme
    Arm Title
    Usual care group
    Arm Type
    No Intervention
    Arm Description
    Usual care
    Intervention Type
    Other
    Intervention Name(s)
    Clinical practice guideline for prevention and management of extravasation injury
    Intervention Description
    Implementation of an evidence-based clinical practice guideline and delivery of an educational programme for nurses
    Primary Outcome Measure Information:
    Title
    Change in rate of peripheral intravenous extravasation
    Description
    The number of the incidents divided by the total number of catheter days and multiplied by 1,000
    Time Frame
    Change from Baseline rate at one month
    Title
    Change in rate of extravasation from a central line
    Description
    The number of the incidents divided by the total number of catheter days and multiplied by 1,000
    Time Frame
    Change from Baseline rate at one month
    Secondary Outcome Measure Information:
    Title
    Change in nurses' level of knowledge
    Description
    The Neonatal Extravasation Knowledge Test
    Time Frame
    Change from Baseline Knowledge level at six months
    Title
    Change in nurses' adherence to clinical practice guidelines
    Description
    A 27-item audit tool
    Time Frame
    Change from Baseline Adherence level at six months

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    1 Year
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Neonates who were admitted for intravenous medication or infusion therapy, and Neonates whose parents were equal to or over 18 years old and able to communicate in Chinese or English. Exclusion Criteria: Neonates who were born with congenital dermatological problems such as ichthyosis and epidermolysis bullosa.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kam Ming Chan
    Organizational Affiliation
    United Christian Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32967637
    Citation
    Chan KM, Chau JPC, Choi KC, Fung GPG, Lui WW, Chan MSY, Lo SHS. Clinical practice guideline on the prevention and management of neonatal extravasation injury: a before-and-after study design. BMC Pediatr. 2020 Sep 23;20(1):445. doi: 10.1186/s12887-020-02346-9.
    Results Reference
    derived

    Learn more about this trial

    Clinical Practice Guideline for Neonatal Extravasation Injury

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