The goal of this clinical trial is to compare late preterm newborn lung physiology when supported with different continuous positive airway pressure (CPAP) devices. The main questions it aims to answer are: * Which CPAP modality provides better breathing support in newborns with respiratory distress syndrome who are greater than 32 weeks gestational age? * Does the lung physiology data predict the CPAP modality that will result in a shorter CPAP treatment duration? Participants will wear a belt of electrodes on their chest (electrical impedance tomography) and have an esophageal balloon manometry measure lung physiology data for 2.5 hours while switching CPAP devices. Participants will then be randomly assigned to a CPAP device to support their breathing until they recover from respiratory distress syndrome.
Across centers, there is a variation in standard of care for the preferred device and interface to deliver continuous positive airway pressure (CPAP) to support neonatal functional residual capacity. CPAP, a type of noninvasive respiratory support, is commonly delivered to neonates by mechanical ventilators or underwater bubble devices (bubble CPAP). Variation also exists with the tubing used to deliver CPAP. One commonly used nasal interface is the RAM cannula (Neotech, Valencia, CA), made of a soft material with thin tubing walls and is designed to provide 60-80% occlusion of the nares. This contrasts with the occlusive interface intended to provide complete seal. To provide evidence for standardization of CPAP delivery, clinical trials are needed to assess which modality of CPAP delivery is optimal for neonates with respiratory distress syndrome who are \> 32 weeks and \<37 weeks gestational age, an understudied population. The investigators propose to use electrical impedance tomography (EIT) paired with esophageal balloon manometry to assess neonatal lung physiology when supported with different modalities of CPAP. Furthermore, participants will be randomly assigned to A) physiology based CPAP vs B) one size fits all approach. The subjects will remain on the assigned modality of CPAP for the remainder of their respiratory distress syndrome treatment, and researchers will track which modality of CPAP results in a shorter CPAP treatment period and if this is expected based on the lung physiology data collected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
RAM cannula ventilator CPAP
Occlusive interface bubble CPAP
Massachusetts General Hospital
Boston, Massachusetts, United States
change in electrical impedance
change in average electrical impedance with each CPAP delivery modality
Time frame: 2.5 hours during the lung physiology assessment
duration of CPAP treatment
compare groups Arm A-1, A-2 vs Arm B-1, B2; Compare groups Arm A-1, B-1 vs Arm A-2, B-2
Time frame: through study completion, an average of 2 weeks after the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in end expiratory lung impedance
change in end expiratory lung impedance (arbitrary units)
Time frame: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) vascular pulsatility
vascular pulsatility (arbitrary units)
Time frame: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) tidal volume
tidal volume (in milliliters) per weight (in kilograms)
Time frame: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in minute ventilation
change in minute ventilation (mL/minute)
Time frame: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in dynamic compliance
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change in dynamic compliance (mL/cmH2O)
Time frame: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Respiratory rate
Respiratory rate (breaths per minute)
Time frame: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Oxygen saturation
Oxygen saturation (percentage)
Time frame: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Abdominal circumference
Abdominal circumference (cm)
Time frame: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) esophageal pressure change
esophageal pressure change (mm Hg)
Time frame: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) end expiratory pressure
end expiratory pressure via esophageal balloon manometry (mm Hg)
Time frame: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) pressure rate product
pressure rate product (cm H2O / min)
Time frame: 2.5 hours during the lung physiology assessment
clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) Frequency of deviation
frequency of deviation from assigned CPAP treatment (percentage)
Time frame: through study completion, an average of 2 weeks after the lung physiology assessment
clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) frequency of exogenous surfactant administration
frequency of exogenous surfactant administration (percentage)
Time frame: through study completion, an average of 2 weeks after the lung physiology assessment
clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial)
respiratory support settings if deviated from assigned CPAP treatment (percentage)
Time frame: through study completion, an average of 2 weeks after the lung physiology assessment