NCT04321447

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2017

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 20, 2020

Last Update Submit

March 23, 2020

Conditions

Keywords

Intravenous nursingNewborn infantNeonatal intensive care unitsEvidence-based professional practice

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

EXPERIMENTAL

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

Usual care group

NO INTERVENTION

Usual care

Interventions

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

Clinical practice guideline (CPG) group

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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.

Study Officials

  • Kam Ming Chan

    United Christian Hospital

    PRINCIPAL INVESTIGATOR

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