Health TrialsbyHealthPanel

Non-Invasive Ventilation Interfaces and Nasal Pressure Injury in Preterm Infants

ConditionsMedical Device-Related Pressure InjuryPrematurity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-28
SponsorIstanbul University - Cerrahpasa

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Infants requiring intubation

Presence of congenital anomalies

Pre-existing nasal injury or trauma

Presence of skin disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Binasal Prong

    Device

    Continuous positive airway pressure (CPAP) delivered via binasal prong interface.

  • Nasal Cannula

    Device

    Continuous positive airway pressure (CPAP) delivered via nasal cannula.

  • Nasal Mask

    Device

    Continuous positive airway pressure (CPAP) delivered via nasal mask interface.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Binasal ProngExperimental treatment 1 intervention
Group B: Nasal CannulaExperimental treatment 1 intervention
Group C: Nasal MaskExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Within 96 hours (4 days) after initiation of non-invasive ventilation

Secondary outcomes

1

Severity of Nasal Pressure Injury

Severity of nasal pressure injury assessed using a standardized pressure injury staging scale.

Time frame
Every 12 hours for 96 hours
2

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.

Time frame
Every 12 hours for 96 hours
3

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.

Time frame
Every 12 hours for 96 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istanbul University - Cerrahpasa

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: