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

NCT04165382 | Unknown

• 1 other identifier: KC/KE-19-0093/ER-1
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

nurse care; non-invasive ventilation; preterm infants

Outcome Measures

Primary Outcomes (5)

• nasal injury

  infant's severity of nasal injury rated by the staging system from National Pressure Ulcer Advisory Panel

  receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group

• pain level

  infant's pain level rated by the Neonatal Pain, Agitation and Sedation Scale (N-PASS) with minimum score at 0 and maximum score at 11 for preterm \< 30 weeks \& 10 for infants \> or = 30 weeks. To study whether the interventions of the guideline can promote comfort for preterm infants receiving NIV, by studying indirectly on the pain level. For each infant participant, baseline of pain level will be obtained at the beginning of NIV, then pain score will be assessed every shift or every routine care (at least 4 hours) if the baseline score \>3. If the pain score reduce or remain unchanged after implementation of the guideline, it shows the comfort of the infants receiving NIV

  receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group

• activity level

  infant's activity level including sleep, active, quiet, irritable and unresponsive evaluated in hourly nursing assessment

  receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group

• body weight

  infant's body weight weighed by the baby weight scale every alternate day

  receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group

• abdominal girth

  infant's abdominal girth by the measuring tape every morning before feeding

  receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group

Secondary Outcomes (4)

• knowledge level of caring infants receiving NIV

  once before the training, once just after the training, once at 12-week after completion of the one-month training in the NICU

• Compliance to the guideline

  once as baseline record in the pre-implementation period, once at 12-week and once at 24-week since the commencement of post-implementation period

• ventilation day

  receiving ventilation support through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group

• Efficacy of NIV

  receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group

Study Arms (2)

Pre-implementation study group

OTHER

Preterm infants receiving NIV before the implementation of the guideline

Other: Usual care to infants receiving NIV

Post-implementation study group

OTHER

Preterm infants receiving NIV after the implementation of the guideline

Other: Interventions in the guideline to infants receiving NIV

Interventions

Interventions in the guideline to infants receiving NIV OTHER

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

Also known as: care bundle of the guideline

Post-implementation study group

Usual care to infants receiving NIV OTHER

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.

Also known as: Usual care

Pre-implementation study group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• the infant born before 37 completed weeks of gestation age
• receiving or started NIV via nasal prong or nasal mask at the supports as
• continuous positive airway pressure
• non-invasive intermittent positive pressure ventilation
• neural adjusted ventilatory assisted ventilation

You may not qualify if:

• infants with the chromosomal abnormalities (e.g. Pierre Robin Sequence)
• complex heart problems (e.g. transposition of great arteries, Tetralogy of Fallot, Coarctation of Aorta)
• severe respiratory disorders/diseases (e.g. diaphragmatic hernia, tracheoesophageal fistula, cystic fibrosis, congenital cystic adenomatoid malformation)
• craniofacial anomalies (e.g. bilateral cleft lip,cleft palate, choanal atresia)
• congenital skin disorders (e.g. collodion baby)
• severe acute conditions (e.g. necrotizing enterocolitis, pneumothorax, intraventricular haemorrhage, severe sepsis)
• parents or legal guardian refuse to join the study

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• The Queen Elizabeth Hospital: collaborator

Study Sites (1)

Queen Elizabeth Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Sin Yee Chan

  The Queen Elizabeth Hospital

  PRINCIPAL INVESTIGATOR

• Janita Chau, Professor

  Chinese University of Hong Kong

  STUDY CHAIR

Central Study Contacts

Sin Yee CHAN

CONTACT

+852-3506 7751; 1155101742@link.cuhk.edu.hk

Janita Chau, Professor

CONTACT

+852-39436226

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking will be applied to the Assessor who is responsible for auditing nurses' compliances to the guideline in the NICU. The Assessor is asked to perform audits regarding the care to infants receiving NIV in the pre-implementation period and post-implementation period without informing him/her for the study period.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Consultant (Neonatal Care)

Model Details: Usual care will be provided to the study group of the Pre-implementation period, and interventions in the guideline will be started to provide to the study group in the Post-implementation period.

Study Record Dates

• First Submitted: November 10, 2019
• First Posted: November 18, 2019
• Study Start: October 2, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)