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Development, Implementation and Evaluation of a Clinical Practice Guideline for Care of Preterm Infants Receiving Non-invasive Ventilation (NIV)

NCT04165382 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2019-11-18

No results posted yet for this study

Summary

Non-invasive ventilation (NIV) is increasingly used for supporting preterm infants with respiratory distress in the Neonatal Intensive Care Unit (NICU), and the incidence for nasal injury including skin redness or breakdown associated with pressure from the nasal interfaces is found in infants receiving this support. Risk is found higher in preterm infants than term infants due to the smaller gestation age and lower birth weight. Thus, the study aims to develop, implement, and evaluate an evidence-based practice guideline (the guideline) for preterm infants receiving NIV in the NICU. With the implementation of this guideline, it helps to promote comfort to infants receiving NIV, and at the same time to minimize complications associated with NIV.

Conditions

  • Noninvasive Ventilation

Interventions

OTHER

Interventions in the guideline to infants receiving NIV

Interventions in the guideline involve six components as 1. choice of "right" nasal interfaces and bonnet 2. use of skin protective dressing 3. alternate the nasal interfaces every 6 hours; 4. positioning the infants at optimal developmental body position without prone every 4-6 hours, and well supporting the devices to prevent displacement and traction 5. supportive care with more new interventions 6. regular assessments on infants receiving NIV for pain level and skin integrity for the areas in contacting with the nasal interfaces and devices of NIV

OTHER

Usual care to infants receiving NIV

Usual care includes the choice of nasal interface for NIV; use of skin protective dressing; positioning of infants without specific frequency or types of position; supportive care as to provide humidification to the ventilator circuit, to remove water condensate in the ventilator circuit, to provide oral care every 3-4 hours and avoid unnecessary nasal suctioning.

Sponsors & Collaborators

  • The Queen Elizabeth Hospital

    collaborator OTHER

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Sin Yee Chan · The Queen Elizabeth Hospital

  • Janita Chau, Professor · Chinese University of Hong Kong

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-02
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04165382 on ClinicalTrials.gov