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| Name | Class |
|---|---|
| The Queen Elizabeth Hospital | OTHER |
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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.
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-implementation study group | Other | Preterm infants receiving NIV before the implementation of the guideline |
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| Post-implementation study group | Other | Preterm infants receiving NIV after the implementation of the guideline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interventions in the guideline to infants receiving NIV | Other | Interventions in the guideline involve six components as
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| knowledge level of caring infants receiving NIV | self-developed questions as "pre-test" and "post-test" to assess nurses' knowledge of caring infants receiving NIV, the minimum score of the test is 0 and maximum is 10, the differences between the score obtained in "pre-test" and "post-test" indicates any increase of 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sin Yee CHAN | Contact | +852-3506 7751 | 1155101742@link.cuhk.edu.hk | |
| Janita Chau, Professor | Contact | +852-39436226 |
| Name | Affiliation | Role |
|---|---|---|
| Sin Yee Chan | The Queen Elizabeth Hospital | Principal Investigator |
| Janita Chau, Professor | Chinese University of Hong Kong | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Hospital | Recruiting | Hong Kong | Hong Kong |
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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.
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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.
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| 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. |
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| receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group |
| Compliance to the guideline | self-developed audit tool to assess nurses' 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 | total ventilation days for infant receiving NIV and receiving invasive ventilation before changed to NIV | 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 | study the total ventilation day for infants receiving NIV, and any failure of NIV as indicated by infant requiring intubation for the invasive ventilation within 24-hour after receiving NIV | receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group |
| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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