Mechanical Ventilation ComplicationNCT06642285
Effect of Implementing Evidence Based Practices on Prevention of Associated Nasal Pressure Injuries Among Preterm Neonates With Non-Invasive Respiratory Support
A study testing Non Invasive Respiratory Support bundle in people with Mechanical Ventilation Complication and Respiratory Distress Syndrome in Premature Infant, run by Kafrelsheikh University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Mechanical Ventilation Complication, Respiratory Distress Syndrome in Premature Infant
- What is being tested?
- Non Invasive Respiratory Support bundle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 30 Jan 2025
- 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 30 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm neonates receiving NIRS
- whose gestational ages ranges between 30 and 37 weeks, and both genders
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516
Kafrelsheikh University W Kafr Ash Shaykh, Ass. Professor, 01065407334, emanfadl2811@gmail.com
Eman W Wardany, Ass. Professor, 01065407334, emanfadl2811@gmail.com
About this study
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
Read the 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.
- Being tested
- Non Invasive Respiratory Support bundle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Invasive Respiratory Support bundleProcedure or surgery
premature neonates who will receive evidence-based guidelines for prevention of nasal pressure injuries associated with non invasive respiratory support till weaning
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | : it will include thirty premature neonates who will receive the usual hospital care in accordance with hospital protocols, without any extra procedures or therapies. |
| Bundle group | Experimental | : it will include thirty premature neonates who will receive evidence-based guidelines on the prevention of nasal pressure injuries in form of a care bundle from the first day of providing NIRS till weaning. Receives: Procedure: Non Invasive Respiratory Support bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from the baseline nasal skin integrity on Nasal injury classification tool
: it is adopted from (Fischer et al., 2010) based on the standardized classification of the decubitus lesions from the US National Pressure Ulcer Advisory Panel (NPUAP) (Black et al., 2007; The National Pressure Ulcer Advisory Panel, 1989). This tool will be employed to describe and track the progression and severity of nasal injuries caused by NIRS in neonates by assessing nasal region (the nasal tip, nasal septum, nostril, and nose shape change) for erythema, ulceration, and necrosis, in order to ensure proper and early treatment
Measured: 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)
It will be adopted from (Stevens et al., 1996). The Premature Infant Pain Profile (PIPP) is a biobehavioral observational technique used to quantify acute and procedure pain in premature infants. It assesses seven indicators: gestational age, behavioral state, increased heart rate, decreased oxygen saturation, forehead bulging, eye squeezing, and nasolabial furrows. Each indicator is scored on a four-point Likert scale, from 0 to 3. The total PIPP score, which is the sum of points for all seven indications, varies between 0 to 21. Higher scores imply more painful conduct. A number of 0-6 indicates no pain, 7-12 indicates mild to moderate pain, and a score more than 12 indicates severe pain.
Measured: - 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Aug 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Wardany Abdelaal Mohamed, Kafrelsheikh University
- Investigators
- Eman W Wardany, ass. professor, Principal investigator, pediatric nursing department, faculty of nursing kafrelsheikh univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642285
- Sponsor's protocol ID
- KafrelsheikhU4
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Implementing Evidence Based Practices on Prevention of Associated Nasal Pressure Injuries Among Preterm Neonates With Non-Invasive Respiratory Support
- ClinicalTrials.gov ID
- NCT06642285
- Acronym / sponsor ID
- KafrelsheikhU4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 15 Oct 2024 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –: it will include thirty premature neonates who will receive the usual hospital care in accordance with hospital protocols, without any extra procedures or therapies. |
| Bundle group | Experimental | Procedure: Non Invasive Respiratory Support bundle: it will include thirty premature neonates who will receive evidence-based guidelines on the prevention of nasal pressure injuries in form of a care bundle from the first day of providing NIRS till weaning. |
Who may qualify
- Ages
- 30 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm neonates receiving NIRS
- whose gestational ages ranges between 30 and 37 weeks, and both genders
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Non Invasive Respiratory Support bundlepremature neonates who will receive evidence-based guidelines for prevention of nasal pressure injuries associated with non invasive respiratory support till weaning | Procedure or surgery | Bundle group |
Primary outcome
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.
: it is adopted from (Fischer et al., 2010) based on the standardized classification of the decubitus lesions from the US National Pressure Ulcer Advisory Panel (NPUAP) (Black et al., 2007; The National Pressure Ulcer Advisory Panel, 1989). This tool will be employed to describe and track the progression and severity of nasal injuries caused by NIRS in neonates by assessing nasal region (the nasal tip, nasal septum, nostril, and nose shape change) for erythema, ulceration, and necrosis, in order to ensure proper and early treatment
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
It will be adopted from (Stevens et al., 1996). The Premature Infant Pain Profile (PIPP) is a biobehavioral observational technique used to quantify acute and procedure pain in premature infants. It assesses seven indicators: gestational age, behavioral state, increased heart rate, decreased oxygen saturation, forehead bulging, eye squeezing, and nasolabial furrows. Each indicator is scored on a four-point Likert scale, from 0 to 3. The total PIPP score, which is the sum of points for all seven indications, varies between 0 to 21. Higher scores imply more painful conduct. A number of 0-6 indicates no pain, 7-12 indicates mild to moderate pain, and a score more than 12 indicates severe pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- 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.
Eman W Wardany, ass. professor principal investigator
pediatric nursing department, faculty of nursing kafrelsheikh univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non Invasive Respiratory Support bundle in people with Mechanical Ventilation Complication and Respiratory Distress Syndrome in Premature Infant, run by Kafrelsheikh University at 1 site in Egypt.
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 2 inclusion and 5 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 15 Oct 2024. 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 Egypt. 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 Eman W abdelaal, Ass. Professor (01065407334, eman_wardany_2014@nur.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 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 15 Oct 2024.