Clinical Practice Guideline for Neonatal Extravasation Injury

Extravasation Injury Clinical Trial

Official title:

Clinical Practice Guideline on the Prevention and Management of Neonatal Extravasation Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04321447
• Other study ID #: CPGneonatalextravasation
• Status: Completed
• Phase: N/A
• Start date: November 14, 2015
• Est. completion date: August 29, 2017

Study information

• Verified date: March 2020
• Source: United Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: August 29, 2017
• Est. primary completion date: November 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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.

Related Conditions & MeSH terms

• Extravasation Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
United Christian Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in nurses' level of knowledge	The Neonatal Extravasation Knowledge Test	Change from Baseline Knowledge level at six months
Secondary	Change in nurses' adherence to clinical practice guidelines	A 27-item audit tool	Change from Baseline Adherence level at six months