Clinical trial NCT06642285: Effect of Implementing Evidence Based Practices on Prevention of Associated Nasal Pressure Injuries Among Preterm Neonates With Non-Invasive Respiratory Support
Official title: Effect of Implementing Evidence Based Practices on Prevention of Associated Nasal Pressure Injuries Among Preterm Neonates With Non-Invasive Respiratory Support
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mechanical Ventilation Complication
Respiratory Distress Syndrome in Premature Infant
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the effect of implementing evidence based practices on prevention of associated nasal pressure injuries among preterm neonates with non invasive respiratory support

Detailed description: The researchers explained the study's aim, benefits, and procedures for participation, after that the parents of the neonates provided an informed consent. Over a one-week period, staff education programs regarding Evidence-Based Guidelines for non-invasive respiratory support will be conducted for NICU nursing staff. These sessions, lasting 15 to 20 minutes, will be held during regularly scheduled work hours, with four different sessions will offer throughout the day. The preterm neonates' characteristics and clinical data will be extracted from their hospital records for the two groups on the first day of admission for both groups prior to intervention to identify those who fulfilled the current study's inclusion criteria. Neonatal baseline data was collected from their records on the first day of admission for the two groups prior to intervention in order to identify neonates who meet the required criteria of the study. Then the participants were selected and divided randomly (using a simple random method) into two equal groups. One subject for the control group, one for the study group and so on, distributed the participants into two equivalent groups as fellow:

Control Group: Consisted of 30 premature neonates who will receive conventional hospital care with no additional interventions.

Study Group: Consisted of 30 premature neonates who will receive 6 evidence-based practices on the prevention of nasal pressure injuries as follows:

* Use an appropriately sized nasal interface device.
* The Use of Skin Barrier Products between nasal skin and nasal interface device
* Visually examining the preterm newborn every hour to ensure appropriate nasal interface position
* Once every 12-hour shift, the protective barrier and nasal device are briefly removed to allow for a full nasal skin examination
* Follow developmental care principles by repositioning the infant every three to four hours.
* Pain scores should be taken at least every three to four hours.

Eligibility criteria: Inclusion Criteria:

* Preterm neonates receiving NIRS
* whose gestational ages ranges between 30 and 37 weeks, and both genders

Exclusion Criteria:

* all preterm neonates not receiving NIRS,
* have prior nasal trauma caused by tracheal intubation
* or Infants exhibiting evidence of nasal damage during the NIRS procedure,
* have upper respiratory abnormalities.
* preterm neonates who have undergone any type of surgery and had life-threatening congenital abnormalities.

Primary outcomes:
measure: change from the baseline nasal skin integrity on Nasal injury classification tool
timeFrame: Researchers will assess the nasal skin of preterm infants every 3-6 hours from the first day of providing NIRS till 14 days to determine the nasal damage score in both groups.
measure: change from the baseline pain score on Premature Infant Pain Profile (PIPP)
timeFrame: - Researchers will evaluate pain scores for preterm infants in both groups every 3-4 hours from the first day of providing NIRS till 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafr el-Sheikh
Study officials:
affiliation: pediatric nursing department, faculty of nursing kafrelsheikh univeristy
name: Eman W Wardany, ass. professor
role: PRINCIPAL_INVESTIGATOR
References: