Extravasation InjuryNCT04321447
Clinical Practice Guideline for Neonatal Extravasation Injury
A study testing Clinical practice guideline for prevention and management of extravasation injury in people with Extravasation Injury, run by United Christian Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Extravasation Injury
- What is being tested?
- Clinical practice guideline for prevention and management of extravasation injury
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- No sites listed yet
- Study dates
- 14 Nov 2015to 29 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Neonates who were born with congenital dermatological problems such as ichthyosis and epidermolysis bullosa.
About this study
Official title: Clinical Practice Guideline on the Prevention and Management of Neonatal Extravasation Injury
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.
Read the 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.
- Conditions
- Extravasation Injury
- Being tested
- Clinical practice guideline for prevention and management of extravasation injury
- Keywords
- Intravenous nursing, Newborn infant, Neonatal intensive care units, Evidence-based professional practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical practice guideline for prevention and management of extravasation injuryOther
Implementation of an evidence-based clinical practice guideline and delivery of an educational programme for nurses
| Study group | Role | What they receive |
|---|---|---|
| Clinical practice guideline (CPG) group | Experimental | Implementation of an evidence-based clinical practice guideline and delivery of an educational programme Receives: Other: Clinical practice guideline for prevention and management of extravasation injury |
| Usual care group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Change from Baseline rate at one month
Secondary outcomes (2)
Change in nurses' level of knowledge
The Neonatal Extravasation Knowledge Test
Measured: Change from Baseline Knowledge level at six months
Change in nurses' adherence to clinical practice guidelines
A 27-item audit tool
Measured: Change from Baseline Adherence level at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start14 Nov 2015
- Primary completion23 Nov 2016
- Study completion29 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extravasation InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHAN Kam Ming, United Christian Hospital
- Investigators
- Kam Ming Chan, Principal investigator, United Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321447
- Sponsor's protocol ID
- CPGneonatalextravasation
- Status last verified
- Mar 2020
- First submitted
- 20 Mar 2020
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32967637
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Practice Guideline on the Prevention and Management of Neonatal Extravasation Injury
- ClinicalTrials.gov ID
- NCT04321447
- Acronym / sponsor ID
- CPGneonatalextravasation
- Conditions
- Extravasation Injury
- Keywords
- Intravenous nursing, Newborn infant, Neonatal intensive care units, Evidence-based professional practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- United Christian HospitalUniversity, hospital or other
- Study start
- 14 Nov 2015 (actual)
- Primary completion
- 23 Nov 2016 (actual)
- Study completion
- 29 Aug 2017 (actual)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical practice guideline (CPG) group | Experimental | Other: Clinical practice guideline for prevention and management of extravasation injuryImplementation of an evidence-based clinical practice guideline and delivery of an educational programme |
| Usual care group | No intervention | –Usual care |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Neonates who were born with congenital dermatological problems such as ichthyosis and epidermolysis bullosa.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical practice guideline for prevention and management of extravasation injuryImplementation of an evidence-based clinical practice guideline and delivery of an educational programme for nurses | Other | Clinical practice guideline (CPG) group |
Primary outcome
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
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
2 secondary outcomes
Change in nurses' level of knowledge
Time frame: Change from Baseline Knowledge level at six months
Change in nurses' adherence to clinical practice guidelines
Time frame: Change from Baseline Adherence level at six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 32967637Chan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kam Ming Chan principal investigator
United Christian Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Clinical practice guideline for prevention and management of extravasation injury in people with Extravasation Injury, run by United Christian Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rate of peripheral intravenous extravasation (time frame: Change from Baseline rate at one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04321447, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.