Clinical trial NCT04165382: Development, Implementation and Evaluation of a Clinical Practice Guideline for Care of Preterm Infants Receiving Non-invasive Ventilation (NIV)
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Noninvasive Ventilation
Keywords: nurse care
non-invasive ventilation
preterm infants
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Queen Elizabeth Hospital
First posted: 2019-11-18
Enrollment: 176
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: nasal injury
timeFrame: receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group
measure: pain level
timeFrame: receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group
measure: activity level
timeFrame: receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group
measure: body weight
timeFrame: receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group
measure: abdominal girth
timeFrame: receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group
Secondary outcomes:
measure: knowledge level of caring infants receiving NIV
timeFrame: once before the training, once just after the training, once at 12-week after completion of the one-month training in the NICU
measure: Compliance to the guideline
timeFrame: 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
measure: ventilation day
timeFrame: receiving ventilation support through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group
measure: Efficacy of NIV
timeFrame: receiving NIV through study period completion, an average of 6 months for pre-implementation group, and 8 months for post-implementation group
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital
Study officials:
affiliation: The Queen Elizabeth Hospital
name: Sin Yee Chan
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese University of Hong Kong
name: Janita Chau, Professor
role: STUDY_CHAIR
References: