Noninvasive VentilationNCT04165382
Development, Implementation and Evaluation of a Clinical Practice Guideline for Care of Preterm Infants Receiving Non-invasive Ventilation (NIV)
A study testing Interventions in the guideline to infants receiving NIV in people with Noninvasive Ventilation, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Noninvasive Ventilation
- What is being tested?
- Interventions in the guideline to infants receiving NIV
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Oct 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Janita Chau, Professor contact
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Elizabeth Hospital
Hong Kong
Sin Yee Chan, +852-35067751, bcsyz05@ha.org.hk
Sin Yee Chan
About this study
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)
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.
Read the detailed 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
- 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.
- use of skin protective dressing, in which the hydrocolloid dressing is used to cover the skin areas underneath the nasal interface and anchoring straps;
- alternate the nasal interfaces from the short binasal prongs to nasal mask every 6 hours;
- 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;
- 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;
- 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.
- Conditions
- Noninvasive Ventilation
- Being tested
- Interventions in the guideline to infants receiving NIV, Usual care to infants receiving NIV
- Keywords
- nurse care, non-invasive ventilation, preterm infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventions in the guideline to infants receiving NIVOther
Also called care bundle of the guideline
Interventions in the guideline involve six components as
- choice of "right" nasal interfaces and bonnet
- use of skin protective dressing
- alternate the nasal interfaces every 6 hours;
- positioning the infants at optimal developmental body position without prone every 4-6 hours, and well supporting the devices to prevent displacement and traction
- supportive care with more new interventions
- 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
Usual care to infants receiving NIVOther
Also called Usual care
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-implementation study group | Other | Preterm infants receiving NIV before the implementation of the guideline Receives: Other: Usual care to infants receiving NIV |
| Post-implementation study group | Other | Preterm infants receiving NIV after the implementation of the guideline Receives: Other: Interventions in the guideline to infants receiving NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
nasal injury
infant's severity of nasal injury rated by the staging system from National Pressure Ulcer Advisory Panel
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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
Measured: 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
self-developed audit tool to assess nurses' compliance to the guideline
Measured: 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
Measured: 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
Measured: receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start2 Oct 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noninvasive VentilationStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Queen Elizabeth Hospital
- Responsible party
- Principal investigator, Chan Sin Yee, Chinese University of Hong Kong
- Investigators
- Sin Yee Chan, Principal investigator, The Queen Elizabeth HospitalJanita Chau, Professor, Study chair, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165382
- Sponsor's protocol ID
- KC/KE-19-0093/ER-1
- Status last verified
- Nov 2019
- First submitted
- 10 Nov 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04165382
- Acronym / sponsor ID
- KC/KE-19-0093/ER-1
- Conditions
- Noninvasive Ventilation
- Keywords
- nurse care, non-invasive ventilation, preterm infants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- The Queen Elizabeth Hospital
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- 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.
- use of skin protective dressing, in which the hydrocolloid dressing is used to cover the skin areas underneath the nasal interface and anchoring straps;
- alternate the nasal interfaces from the short binasal prongs to nasal mask every 6 hours;
- 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;
- 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;
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pre-implementation study group | Other | Other: Usual care to infants receiving NIVPreterm infants receiving NIV before the implementation of the guideline |
| Post-implementation study group | Other | Other: Interventions in the guideline to infants receiving NIVPreterm infants receiving NIV after the implementation of the guideline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interventions in the guideline to infants receiving NIVAlso: care bundle of the guidelineInterventions 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 | Post-implementation study group |
| Usual care to infants receiving NIVAlso: Usual careUsual 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. | Other | Pre-implementation study group |
Primary outcome
nasal injury
Time frame: receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group
infant's severity of nasal injury rated by the staging system from National Pressure Ulcer Advisory Panel
pain level
Time frame: receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group
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
activity level
Time frame: receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group
infant's activity level including sleep, active, quiet, irritable and unresponsive evaluated in hourly nursing assessment
body weight
Time frame: receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group
infant's body weight weighed by the baby weight scale every alternate day
abdominal girth
Time frame: receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group
infant's abdominal girth by the measuring tape every morning before feeding
4 secondary outcomes
knowledge level of caring infants receiving NIV
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janita Chau, Professor contact
Sin Yee Chan principal investigator
The Queen Elizabeth Hospital
Janita Chau, Professor study chair
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventions in the guideline to infants receiving NIV in people with Noninvasive Ventilation, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sin Yee CHAN (+852-3506 7751, 1155101742@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nasal injury (time frame: receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.