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Completed

NCT Number: NCT04321447

Clinical Practice Guideline for 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.

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Key information

Conditions

Extravasation Injury

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical practice guideline for prevention and management of extravasation injury

Other

Implementation of an evidence-based clinical practice guideline and delivery of an educational programme for nurses

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Change in nurses' level of knowledge

    Time frame: Change from Baseline Knowledge level at six months

    The Neonatal Extravasation Knowledge Test

  2. Change in nurses' adherence to clinical practice guidelines

    Time frame: Change from Baseline Adherence level at six months

    A 27-item audit tool

Sponsors and collaborators

Lead sponsor

United Christian Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 25, 2020
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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