Medical Device-Related Pressure InjuryNIV-MDRPINCT07521410
Non-Invasive Ventilation Interfaces and Nasal Pressure Injury in Preterm Infants
A study testing Binasal Prong, Nasal Cannula and Nasal Mask in people with Medical Device-Related Pressure Injury and Prematurity, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized controlled clinical trial is to learn whether different non-invasive ventilation interfaces can prevent medical device-related nasal pressure injury in preterm infants receiving respiratory support in a neonatal intensive care unit. Read more about this study
- Who is it for?
- Ages 0 minutes to 28 days
- Conditions the study is for
- Medical Device-Related Pressure Injury, Prematurity
- What is being tested?
- Binasal Prong, Nasal Cannula and Nasal Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2026to 24 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 minutes to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants with a gestational age between 28 and 37 weeks
- Receiving non-invasive ventilation support in a neonatal intensive care unit
- Receiving non-invasive ventilation for at least 4 days
- Parental consent obtained
Who cannot join
- Infants requiring intubation
- Presence of congenital anomalies
- Pre-existing nasal injury or trauma
- Presence of skin disease
- Nasal lesions due to previous nasotracheal intubation
- Upper airway malformations
- Infants transferred from another center after receiving more than 24 hours of non-invasive ventilation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Tekirdag Ismail Fehmi Cumalioglu City Hospital, Neonatal Intensive Care Unit
Tekirdağ
About this study
Official title: Comparison of the Effects of Different Non-Invasive Ventilation Interfaces on the Development of Medical Device-Related Nasal Pressure Injury in Preterm Infants
The goal of this randomized controlled clinical trial is to learn whether different non-invasive ventilation interfaces can prevent medical device-related nasal pressure injury in preterm infants receiving respiratory support in a neonatal intensive care unit.
The main questions it aims to answer are:
Read more
- Do different non-invasive ventilation interfaces affect how often nasal pressure injury develops?
- Do these interfaces affect the severity of nasal pressure injury and the condition of the nasal skin?
Researchers will compare three types of non-invasive ventilation interfaces (binasal prong, nasal cannula, and nasal mask) to see if one method is more effective in reducing nasal pressure injury.
Participants will:
- Be randomly assigned to one of three groups (binasal prong, nasal cannula, or nasal mask)
- Receive non-invasive ventilation support using the assigned interface for at least 4 days
- Have their nasal skin assessed every 12 hours for 96 hours using standardized scales
- Continue to receive routine care in the neonatal intensive care unit
Read the detailed description
This study focuses on medical device-related nasal pressure injury in preterm infants receiving non-invasive ventilation in neonatal intensive care units. Preterm infants are particularly vulnerable to skin injury due to the immaturity of their skin structure and the increased need for respiratory support. Non-invasive ventilation is widely used to reduce lung injury; however, the use of nasal interfaces may lead to pressure-related skin damage, especially in the nasal area.
Previous studies have shown that non-invasive ventilation itself is a risk factor for nasal pressure injury. The type of interface used, such as binasal prong, nasal cannula, or nasal mask, may influence the frequency and severity of these injuries. However, evidence comparing the effectiveness of different interfaces in preventing nasal pressure injury remains limited.
This study is designed as a prospective, randomized controlled trial with a parallel-group design. Preterm infants receiving non-invasive ventilation will be randomly assigned to one of three interface groups: binasal prong, nasal cannula, or nasal mask. Skin condition, pressure injury development, and risk levels will be evaluated using standardized assessment tools, including the Neonatal Skin Risk Assessment Scale (NSRAS), Neonatal Skin Condition Score (NSCS), and Pressure Injury Staging Scale (PISS).
The findings of this study are expected to contribute to evidence-based neonatal nursing care by supporting clinical decision-making in the selection of appropriate ventilation interfaces and improving preventive care strategies for pressure injury in neonatal intensive care units.
- Being tested
- Binasal Prong, Nasal Cannula, Nasal Mask
- Keywords
- Preterm infants, Non-invasive ventilation, Nasal pressure injury, Medical device-related pressure injury, Neonatal intensive care unit, CPAP, Nasal interface
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binasal ProngDevice
Continuous positive airway pressure (CPAP) delivered via binasal prong interface.
Nasal CannulaDevice
Continuous positive airway pressure (CPAP) delivered via nasal cannula.
Nasal MaskDevice
Continuous positive airway pressure (CPAP) delivered via nasal mask interface.
| Study group | Role | What they receive |
|---|---|---|
| Binasal Prong | Experimental | Preterm infants receiving non-invasive ventilation support via binasal prong interface. Receives: Device: Binasal Prong |
| Nasal Cannula | Experimental | Preterm infants receiving non-invasive ventilation support via nasal cannula interface. Receives: Device: Nasal Cannula |
| Nasal Mask | Experimental | Preterm infants receiving non-invasive ventilation support via nasal mask interface. Receives: Device: Nasal Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Medical Device-Related Nasal Pressure Injury
Occurrence of medical device-related nasal pressure injury in preterm infants receiving non-invasive ventilation, assessed using a standardized pressure injury staging scale.
Measured: Within 96 hours (4 days) after initiation of non-invasive ventilation
Secondary outcomes (3)
Severity of Nasal Pressure Injury
Severity of nasal pressure injury assessed using a standardized pressure injury staging scale.
Measured: Every 12 hours for 96 hours
Nasal Skin Condition
Assessment of nasal skin condition using the Neonatal Skin Condition Score (NSCS), which evaluates dryness, erythema, and skin breakdown. The total score ranges from 3 to 9, with higher scores indicating worse skin condition.
Measured: Every 12 hours for 96 hours
Risk of Skin Injury
Evaluation of the risk of skin injury using the Neonatal Skin Risk Assessment Scale (NSRAS). The total score ranges from 6 to 24, with lower scores indicating higher risk of skin injury.
Measured: Every 12 hours for 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion24 Apr 2026 (estimated)
- Study completion24 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Device-Related Pressure InjuryStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Model description
- Participants will be randomly assigned to one of three parallel groups (binasal prong, nasal cannula, or nasal mask) to compare their effects on the development of nasal pressure injury in preterm infants receiving non-invasive ventilation.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Cumur Baskir, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521410
- Sponsor's protocol ID
- İstanbul U-Cerrahpaşa
- Acronym
- NIV-MDRPI
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and legal restrictions regarding the confidentiality of neonatal patient data and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Different Non-Invasive Ventilation Interfaces on the Development of Medical Device-Related Nasal Pressure Injury in Preterm Infants
- ClinicalTrials.gov ID
- NCT07521410
- Acronym / sponsor ID
- NIV-MDRPI / İstanbul U-Cerrahpaşa
- Keywords
- Preterm infants, Non-invasive ventilation, Nasal pressure injury, Medical device-related pressure injury, Neonatal intensive care unit, CPAP, Nasal interface
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 24 Apr 2026 (estimated)
- Study completion
- 24 Oct 2026 (estimated)
- First posted
- 9 Apr 2026 (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.
The goal of this randomized controlled clinical trial is to learn whether different non-invasive ventilation interfaces can prevent medical device-related nasal pressure injury in preterm infants receiving respiratory support in a neonatal intensive care unit.
The main questions it aims to answer are:
- Do different non-invasive ventilation interfaces affect how often nasal pressure injury develops?
- Do these interfaces affect the severity of nasal pressure injury and the condition of the nasal skin?
Researchers will compare three types of non-invasive ventilation interfaces (binasal prong, nasal cannula, and nasal mask) to see if one method is more effective in reducing nasal pressure injury.
Participants will:
- Be randomly assigned to one of three groups (binasal prong, nasal cannula, or nasal mask)
- Receive non-invasive ventilation support using the assigned interface for at least 4 days
- Have their nasal skin assessed every 12 hours for 96 hours using standardized scales
- Continue to receive routine care in the neonatal intensive care unit
Detailed description
This study focuses on medical device-related nasal pressure injury in preterm infants receiving non-invasive ventilation in neonatal intensive care units. Preterm infants are particularly vulnerable to skin injury due to the immaturity of their skin structure and the increased need for respiratory support. Non-invasive ventilation is widely used to reduce lung injury; however, the use of nasal interfaces may lead to pressure-related skin damage, especially in the nasal area.
Previous studies have shown that non-invasive ventilation itself is a risk factor for nasal pressure injury. The type of interface used, such as binasal prong, nasal cannula, or nasal mask, may influence the frequency and severity of these injuries. However, evidence comparing the effectiveness of different interfaces in preventing nasal pressure injury remains limited.
This study is designed as a prospective, randomized controlled trial with a parallel-group design. Preterm infants receiving non-invasive ventilation will be randomly assigned to one of three interface groups: binasal prong, nasal cannula, or nasal mask. Skin condition, pressure injury development, and risk levels will be evaluated using standardized assessment tools, including the Neonatal Skin Risk Assessment Scale (NSRAS), Neonatal Skin Condition Score (NSCS), and Pressure Injury Staging Scale (PISS).
The findings of this study are expected to contribute to evidence-based neonatal nursing care by supporting clinical decision-making in the selection of appropriate ventilation interfaces and improving preventive care strategies for pressure injury in neonatal intensive care units.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups (binasal prong, nasal cannula, or nasal mask) to compare their effects on the development of nasal pressure injury in preterm infants receiving non-invasive ventilation.
| Arm | Type | Receives |
|---|---|---|
| Binasal Prong | Experimental | Device: Binasal ProngPreterm infants receiving non-invasive ventilation support via binasal prong interface. |
| Nasal Cannula | Experimental | Device: Nasal CannulaPreterm infants receiving non-invasive ventilation support via nasal cannula interface. |
| Nasal Mask | Experimental | Device: Nasal MaskPreterm infants receiving non-invasive ventilation support via nasal mask interface. |
Who may qualify
- Ages
- 0 minutes to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preterm infants with a gestational age between 28 and 37 weeks
- Receiving non-invasive ventilation support in a neonatal intensive care unit
- Receiving non-invasive ventilation for at least 4 days
- Parental consent obtained
Key exclusion criteria (7 listed)
- Infants requiring intubation
- Presence of congenital anomalies
- Pre-existing nasal injury or trauma
- Presence of skin disease
- Nasal lesions due to previous nasotracheal intubation
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 |
|---|---|---|
| Binasal ProngContinuous positive airway pressure (CPAP) delivered via binasal prong interface. | Device | Binasal Prong |
| Nasal CannulaContinuous positive airway pressure (CPAP) delivered via nasal cannula. | Device | Nasal Cannula |
| Nasal MaskContinuous positive airway pressure (CPAP) delivered via nasal mask interface. | Device | Nasal Mask |
Primary outcome
Incidence of Medical Device-Related Nasal Pressure Injury
Time frame: Within 96 hours (4 days) after initiation of non-invasive ventilation
Occurrence of medical device-related nasal pressure injury in preterm infants receiving non-invasive ventilation, assessed using a standardized pressure injury staging scale.
3 secondary outcomes
Severity of Nasal Pressure Injury
Time frame: Every 12 hours for 96 hours
Nasal Skin Condition
Time frame: Every 12 hours for 96 hours
Risk of Skin Injury
Time frame: Every 12 hours for 96 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and legal restrictions regarding the confidentiality of neonatal patient data and institutional policies.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binasal Prong, Nasal Cannula and Nasal Mask in people with Medical Device-Related Pressure Injury and Prematurity, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 4 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: opening soon, as of the sponsor's last update on 16 Apr 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esra CUMUR BAŞKIR (+90 541 680 21 59, cumuresra@ogr.iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Medical Device-Related Nasal Pressure Injury (time frame: Within 96 hours (4 days) after initiation of non-invasive ventilation). 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 16 Apr 2026.