Effect of Implementing Evidence Based Practices on Prevention of Associated Nasal Pressure Injuries Among Preterm Neonates With Non-Invasive Respiratory Support
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non Invasive Respiratory Support bundle.
- Who it may be relevant to
- Registry conditions: Mechanical Ventilation Complication, Respiratory Distress Syndrome in Premature Infant. Basic parameters: 30 Weeks — 37 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Non Invasive Respiratory Support bundle
premature neonates who will receive evidence-based guidelines for prevention of nasal pressure injuries associated with non invasive respiratory support till weaning
Primary outcome measures
- change from the baseline nasal skin integrity on Nasal injury classification tool [Time frame: 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.]
- change from the baseline pain score on Premature Infant Pain Profile (PIPP) [Time frame: - 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Kafrelsheikh University — Kafr ash Shaykh
Identifiers
NCT: NCT06642285 · KafrelsheikhU4