Comparison of Leakage With Nasal Prongs and Nasal Mask Interface in Newborns Receiving CPAP Treatment

Study Overview
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Brief Summary
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The study is a two-armed randomized cross-over comparison of leakage with nasal prongs and nasal mask interface in newborn infants treated with CPAP, born after 28 weeks of gestational age. For infants with an interface leakage, the trial also includes an observational part evaluating simple measures to reduce leakage. The study will be carried out in the Karolinska University Hospital Stockholm and in the Östersund Hospital.

Detailed Description
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The study will recruit a total of 50 infants receiving CPAP for respiratory support at the Karolinska University Hospital and the Östersund Hospital. The infant should be stable and not in major respiratory distress. Consent from the parents will be obtained before enrolment. The included infants should have stable spontaneous breathing and be older than 28 weeks (corrected age) at the time of enrolment. The reason for respiratory failure and CPAP treatment is not relevant for study purposes. If an infant cannot participate in the study at a given time, he or she can be enrolled later. A child can only participate once. The primary outcome is leakage. This is recorded using equipment for measuring air flow during CPAP treatment. Measurement of leakage is first performed for one interface and then the next (cross-over). The interface order is randomized. The leakage will be measured after a few minutes of stabilization (part 1). If there is leakage, a few simple measures to reduce the leakage will be evaluated (part 2). The second part will approximately add 10-20 minutes and includes simple measures such as adjusting the nasal mask, closing the mouth, changing the position or changing the size of nasal mask/prongs. Part 1 and part 2 are then repeated for the next interface. If the child shows signs of distress or agitation the measurement will be paused or stopped. Part 1: The CPAP system with the randomized interface (nasal mask or nasal prongs) is applied and adjusted by experienced NICU staff. The staff is blinded for the outcome variable, leakage. The choice of size and other adjustments are guided by clinical experience and not by protocol. The NICU staff is not allowed to participate in the explorative part where measures to reduce leakage are evaluated. This precaution is to avoid staff learning what adjustments affect leakage and influence care of infants enrolled at a later stage. Part 2: In this part the investigators can evaluate the effect of simple measures to minimize the leakage. The level of leakage is displayed on a screen. Examples of measures are; closing the mouth of the infant, adjusting straps, adjusting position and changing the size of the interface. Not every child will undergo all measures to reduce leakage, since the aim of this explorative part is to explore ways to reduce leakage. It is estimated that these tests and measures will take 15-60 minutes per child. No other measurements or follow-up is planned. No blood samples will be collected or analysed. The study will collect information on the infant and the birth. This includes birth weight, gestational age at birth, gender, previous respiratory support and medical history. The main outcome variable is absolute leakage (via mouth or via CPAP interface). Other collected variables are oxygen saturation, respiratory rate, inspired oxygen concentration, apneas, heart rate, if the infant is awake/asleep or in distress. Safety variables include skin irritation or damage of the nose caused by the interface, instability or deterioration of respiration or circulation, problems with the equipment or other adverse events. The investigation can be stopped immediately in the case of distress or instability. The study is, as far as the investigators know, the first one of its kind. The air flow meters do not affect the CPAP system and use a technique that measures the total leakage in L/min. These improvements have been emphasized in previous studies. The study follows GCP (good clinical practice) standards and The Helsinki declaration.

Official Title
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Trial of NCPAP Interface Leakage (ToNIL): A Randomised Crossover Comparison of Leakage With Nasal Prongs and Nasal Mask Interface in Newborn Infants Treated With CPAP

Conditions
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Infant,Premature, Respiration; Insufficient or Poor, Newborn

Intervention / Treatment
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* Device: Nasal mask interface
* Device: Nasal prongs interface


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age over 28 weeks (corrected age) at the time of inclusion Patient receiving respiratory support with CPAP Exclusion Criteria: Airway, pulmonary, cardiac or gastro-intestinal malformations Neuromuscular disease Circulatory unstable patient FiO2 higher than 0.5 Nasal damage or major skin irritation. Extubation less than 24 h before investigation Surgery less than 5 days before investigation

Ages Eligible for Study
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Maximum Age: 44 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Main study design: Two armed randomized cross-over comparison of leakage for two interfaces. The trial also investigates simple measures to reduce leakage (observational)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nasal mask interface<br>The CPAP interface will be applied and adjusted by experienced staff blinded to the outcome variable; leakage. Measures to reduce/minimize leakage are tested in an unblinded observational part after the intervention. | Device: Nasal mask interface<br>* Nasal masks is a standard interface used for CPAP treatment of newborn infants. The CPAP device allows for easily switching between the nasal prongs or nasal mask interface as well as adjustment of size.<br>|
| Active Comparator: Nasal prongs interface<br>The CPAP interface will be applied and adjusted by experienced staff blinded to the outcome variable; leakage. Measures to reduce/minimize leakage are tested in an unblinded observational part after the intervention. | Device: Nasal prongs interface<br>* Nasal masks is a standard interface used for CPAP treatment of newborn infants. The CPAP device allows for easily switching between the nasal prongs or nasal mask interface as well as adjustment of size.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leakage in the CPAP system | Measurement of absolute leakage (at interface or mouth) using flowmeters connected to the CPAP device in flow through position (L/min, 30 seconds recording) | 0-60 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inspired oxygen level (FiO2) | FiO2 level and adjustments needed to maintain pre-intervention baseline peripheral oxygen saturation (SpO2 target range according to local guidelines) | 0-60 min | 
| Level of CPAP support (cmH2O) | CPAP level and adjustments needed to maintain pre-intervention baseline peripheral oxygen saturation (SpO2 target range according to local guidelines) | 0-60 min | 
| Peripheral oxygen saturation (SpO2) | Deviations from baseline and changes requiring adjustment of respiratory support (Outcome 2 and 3) | 0-60 min | 
| Measurement completion possible (yes/no) | The number of infants (ratio of total included patients) where measurement of leakage could be determined (on first or more attempts) | 0-60 min | 
| Effect of simple measures to reduce leakage (L/min) | Lowest level of recorded level of leakage obtainable using simple measures to reduce leakage, guided by leakage monitoring equipment (L/min and measures used to achieve reduction) | 0-60 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous positive airway pressure, Air Leakage, Work of breathing