Clinical Practice Guideline for Neonatal Extravasation Injury

March 23, 2020 updated by: CHAN Kam Ming, United Christian Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

213

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 from Baseline rate at one month
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
Change from Baseline rate at one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in nurses' level of knowledge
Time Frame: Change from Baseline Knowledge level at six months
The Neonatal Extravasation Knowledge Test
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
A 27-item audit tool
Change from Baseline Adherence level at six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United Christian Hospital

Investigators

  • Principal Investigator: Kam Ming Chan, United Christian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2015

Primary Completion (Actual)

November 23, 2016

Study Completion (Actual)

August 29, 2017

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (Actual)

March 25, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPGneonatalextravasation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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