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

Noninvasive Ventilation Clinical Trial

Official title: A Before and After Study for Development, Implementation, and Evaluation of a Clinical Practice Guideline for Care of Preterm Infants Receiving Non-invasive Ventilation (NIV)

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

A workgroup is formed in the NICU to provide expert opinions in the process of development, implementation, and evaluation of the guideline. It consists of five nurses, one neonatologist and one physiotherapist. After that, 16 evidence-based articles were identified in several scientific databases, and practices in the guideline are developed after reviewed and appraised the articles.

Interventions in the guideline involve six components as

1. choice of "right" nasal interfaces, in which the "right" size of nasal interface either short binasal prongs or nasal mask is chosen according to the size of the infant's nose and distance between two nasal nares. In addition, the "right" size of bonnet using to anchoring the ventilator tubing is also selected according to the size of infant's head.

2. use of skin protective dressing, in which the hydrocolloid dressing is used to cover the skin areas underneath the nasal interface and anchoring straps;

3. alternate the nasal interfaces from the short binasal prongs to nasal mask every 6 hours;

4. positioning the infants regularly for 4-6 hours, at optimal developmental body position but avoid prone position, and well supporting the devices to prevent displacement and traction onto the infant's skin after changed position;

5. supportive care including to wet the prongs with sterile water or saline before inserting into the nasal nares, to clean the infant's faces and nasal areas daily, to wipe away any water condensate over infant's nasal areas every 4-6 hours, to gently massage the areas during removal of the nasal interfaces or devices for examination at every routine care, to provide oral care every 3-4 hours and avoid unnecessary nasal suctioning, to provide adequate humidification to the ventilation circuit, to remove water condensate in the interfaces and ventilator circuit, to aspirate air from the gastric tube before every tube feeding to relieve abdominal distension;

6. regular assessments on infants receiving NIV for pain level by Neonatal Pain, Agitation and Sedation Scale, intact of skin integrity for the areas in contacting with the nasal interfaces and devices of NIV, and to rate the severity of injury by the staging system from National Pressure Ulcer Advisory Panel.

The study includes two periods of "pre-implementation" and "post-implementation". In the pre-implementation period, all infants receiving NIV will be providing the usual care including choice of nasal interfaces in which larger or smaller interfaces may be given to the infant, use of skin protective dressing, positioning which is not restricted to the frequency of turning or types of position, supportive care of providing humidification to the ventilator circuit, oral care and avoiding of unnecessary nasal suctioning, removing of water condensate in the ventilator circuit, aspirating of air before alternate tube feeding.

A one-month training will be given to nurses working in the NICU after completion of the pre-implementation period. The training contains a dialect lecture, video demonstration of care, and scenario discussion.

After completion of the one-month training, the post-implementation period will be commenced, and the care in the guideline will be provided to infants receiving NIV.

Data collection on infant participants and nurses will be conducted during the study period.

Data analysis will be performed to evaluate the effectiveness of the guideline as well as the increase of nurses' knowledge in care of infants receiving NIV and their compliances to the guideline. ;

Related Conditions & MeSH terms

• Noninvasive Ventilation
• Premature Birth

• NCT number: NCT04165382
• Study type: Interventional
• Source: Chinese University of Hong Kong
• Contact: Sin Yee CHAN
• Phone: +852-3506 7751
• Email: 1155101742@link.cuhk.edu.hk
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2019
• Completion date: December 31, 2020