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Clinical Practice Guideline for Neonatal Extravasation Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04321447
Recruitment Status : Completed
First Posted : March 25, 2020
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
CHAN Kam Ming, United Christian Hospital

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.

Condition or disease Intervention/treatment Phase
Extravasation Injury Other: Clinical practice guideline for prevention and management of extravasation injury Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Practice Guideline on the Prevention and Management of Neonatal Extravasation Injury
Actual Study Start Date : November 14, 2015
Actual Primary Completion Date : November 23, 2016
Actual Study Completion Date : August 29, 2017

Arm Intervention/treatment
Experimental: Clinical practice guideline (CPG) group
Implementation of an evidence-based clinical practice guideline and delivery of an educational programme
Other: Clinical practice guideline for prevention and management of extravasation injury
Implementation of an evidence-based clinical practice guideline and delivery of an educational programme for nurses

No Intervention: Usual care group
Usual care



Primary Outcome Measures :
  1. Change in rate of peripheral intravenous extravasation [ Time Frame: Change from Baseline rate at one month ]
    The number of the incidents divided by the total number of catheter days and multiplied by 1,000

  2. Change in rate of extravasation from a central line [ Time Frame: Change from Baseline rate at one month ]
    The number of the incidents divided by the total number of catheter days and multiplied by 1,000


Secondary Outcome Measures :
  1. Change in nurses' level of knowledge [ Time Frame: Change from Baseline Knowledge level at six months ]
    The Neonatal Extravasation Knowledge Test

  2. Change in nurses' adherence to clinical practice guidelines [ Time Frame: Change from Baseline Adherence level at six months ]
    A 27-item audit tool



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321447


Sponsors and Collaborators
United Christian Hospital
Investigators
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Principal Investigator: Kam Ming Chan United Christian Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: CHAN Kam Ming, Nurse Consultant, United Christian Hospital
ClinicalTrials.gov Identifier: NCT04321447    
Other Study ID Numbers: CPGneonatalextravasation
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHAN Kam Ming, United Christian Hospital:
Intravenous nursing
Newborn infant
Neonatal intensive care units
Evidence-based professional practice
Additional relevant MeSH terms:
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Wounds and Injuries