Clinical trial NCT05230485: Optimal High CPAP Pressures in Preterm Neonates Post-extubation
Official title: Optimal High CPAP Pressures in Preterm Neonates Post-extubation: A Prospective Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Birth
Mechanical Ventilation Complication
Respiratory Distress Syndrome, Newborn
Keywords: Continuous Positive Airway Pressure
Electrical activity of diaphragm
Continuous distending pressure
Lead sponsor: McMaster Children's Hospital
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 26
Sex: ALL
Minimum age (years): 7
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Use of continuous positive airway pressure (CPAP) in preterm neonates has traditionally been limited to between 5-8 cmH2O. In recent years, use of CPAP pressures ≥9 cmH2O is becoming more common in neonates with evolving chronic lung disease, in lieu of other non-invasive modes or invasive mechanical ventilation. A particular knowledge gap in the current literature is the choice of the level of pressure level when using High CPAP as a post-extubation support mode. In this study, we will comparatively evaluate the short-term impact of two different high CPAP pressures when used as a post-extubation support mode in preterm neonates.

Detailed description: Background: Use of continuous positive airway pressure (CPAP) in preterm neonates has traditionally been limited to between 5-8 cmH2O. In recent years, use of CPAP pressures ≥9 cmH2O is becoming more common in neonates with evolving chronic lung disease, in lieu of other non-invasive modes or invasive mechanical ventilation. However, there are limited data on the effectiveness and safety of this mode.

A particular knowledge gap in the current literature is the choice of the level of pressure level when using High CPAP as a post-extubation support mode. While it could be argued that the initial High CPAP pressure post-extubation should be somewhat higher than the pre-extubation mean airway pressure (Paw), there remain concerns of potential complications as well as uncertainty around degree of leak and resulting effectiveness. On the other hand, a suboptimal post-extubation High CPAP level may lead to atelectasis and contribute towards extubation failure, potentially prolonging invasive ventilation and associated risks. As such, research towards identification of the optimal High CPAP level post-extubation from high invasive ventilation pressures is warranted.

Objective: To comparatively evaluate the short-term impact of two different high CPAP pressures when used as a post-extubation support mode in preterm neonates.

Hypothesis: We hypothesize that babies extubated from invasive mechanical ventilation with a mean Paw between 9-15 cmH2O will demonstrate better physiological and clinical parameters when using High CPAP+2 cmH2O vs equivalent CPAP levels.

Methods: Design - This will be a prospective, single-centre, randomized cross-over study.

Eligibility criteria: Inclusion Criteria:

* Gestational age \<29 weeks; chronological age \>7 days; post-menstrual age \<37 weeks; extubation from invasive ventilation with measured mean airway pressure 9-15 cmH2O

Exclusion Criteria:

* Any congenital or genetic/chromosomal abnormality

Primary outcomes:
measure: Peak Edi
timeFrame: 60 min following each CPAP level - assessed over 10 min
Secondary outcomes:
measure: Minimum EDi
timeFrame: 60 min following each CPAP level - assessed over 10 min
measure: Regional cerebral perfusion
timeFrame: 60 min following each CPAP level - assessed over 10 min
measure: Pressure level - Ventilator
timeFrame: 60 min following each CPAP level - assessed over 10 min
measure: Pressure level - Interface
timeFrame: 60 min following each CPAP level - assessed over 10 min
measure: Work of breathing score
timeFrame: Over entire duration (70 min) at each CPAP level, assessed every 10 min
measure: Heart Rate
timeFrame: Over entire duration (70 min) at each CPAP level, assessed every 10 min
measure: Respiratory Rate
timeFrame: Over entire duration (70 min) at each CPAP level, assessed every 10 min
measure: Transcutaneous CO2 level
timeFrame: Over entire duration (70 min) at each CPAP level, assessed every 10 min
measure: FiO2 level
timeFrame: Over entire duration (70 min) at each CPAP level, assessed every 10 min
measure: Number of bradycardic episodes <80 bpm
timeFrame: Over entire duration (70 min) at each CPAP level
measure: Proportion of duration with SpO2 <90%
timeFrame: Over entire duration (70 min) at each CPAP level
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
Study officials:
affiliation: Associate Professor
name: Amit Mukerji, MD
role: PRINCIPAL_INVESTIGATOR
References: