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
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
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
NCT ID
NCT04321447
First Posted
March 20, 2020
Last Updated
March 23, 2020
Sponsor
United Christian Hospital
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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