Clinical Practice Guideline for Neonatal Extravasation Injury
Clinical Practice Guideline on the Prevention and Management of Neonatal Extravasation Injury
1 other identifier
interventional
213
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2017
CompletedFirst Submitted
Initial submission to the registry
March 20, 2020
CompletedFirst Posted
Study publicly available on registry
March 25, 2020
CompletedMarch 25, 2020
March 1, 2020
1 year
March 20, 2020
March 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 from Baseline rate at one month
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
Change from Baseline rate at one month
Secondary Outcomes (2)
Change in nurses' level of knowledge
Change from Baseline Knowledge level at six months
Change in nurses' adherence to clinical practice guidelines
Change from Baseline Adherence level at six months
Study Arms (2)
Clinical practice guideline (CPG) group
EXPERIMENTALImplementation of an evidence-based clinical practice guideline and delivery of an educational programme
Usual care group
NO INTERVENTIONUsual care
Interventions
Implementation of an evidence-based clinical practice guideline and delivery of an educational programme for nurses
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Neonates who were born with congenital dermatological problems such as ichthyosis and epidermolysis bullosa.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 32967637DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Kam Ming Chan
United Christian Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nurse Consultant
Study Record Dates
First Submitted
March 20, 2020
First Posted
March 25, 2020
Study Start
November 14, 2015
Primary Completion
November 23, 2016
Study Completion
August 29, 2017
Last Updated
March 25, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share