Prematurity, Respiratory Distress Syndrome
Conditions
Keywords
continuous positive airway pressure
Brief summary
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.
Detailed description
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.
Interventions
DEVICERAM cannula ventilator CPAP
RAM cannula ventilator CPAP
DEVICEOcclusive interface bubble CPAP
Occlusive interface bubble CPAP
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Given the nature of CPAP, it is not possible to mask which CPAP device the subject is supported by, but the participant, care provider, and outcomes assessor will be masked to whether the subject was randomized to arm A (the device the lung physiology assessment deemed superior for that subject) or arm B (random assignment to the CPAP device, not taking into account the subject's lung physiology).
Intervention model description
Lung physiology measurements with electrical impedance tomography and esophageal manometry will be collected while the participant is supported with RAM cannula ventilator CPAP followed by occlusive interface ventilator CPAP followed by occlusive interface bubble CPAP. A 1:1 block randomization of either A) physiology-based CPAP or B) one size fits all CPAP of either RAM cannula ventilator CPAP or occlusive interface bubble CPAP will be assigned to the participant. Arm B is further randomized 1:1 to either RAM cannula ventilator CPAP or occlusive interface bubble CPAP. The duration of CPAP treatment will be compared between the two arms (precision medicine approach vs standard of care) as well as compare each device and whether the physiology data would have predicted the CPAP device would have resulted in a shorter treatment period.
Eligibility
Sex/Gender
ALL
Age
12 Hours to 36 Hours
Healthy volunteers
No
Inclusion criteria
* medically stable neonates born \>32 0/7 weeks and \< 37 0/7 weeks gestational age, with birth weights \> 1500 grams, are chronologically 12-36 hours old, and are receiving RAM cannula ventilator CPAP with positive end expiratory pressure (PEEP) between 5-6 cm water (H2O) and Fraction of inspired oxygen (FiO2) \< 0.3 for the suspected diagnosis of respiratory distress syndrome
Exclusion criteria
* neonates with congenital anomalies that potentially will affect respiratory physiology, for example hypoplastic lungs or gastroschisis. * neonates with contraindications for wearing an occlusive interface, for example epidermolysis bullosa which may have risk of worsening skin integrity at the pressure points of the occlusive interface, or a known small air leak that may potentially develop into a large pneumothorax. * neonates with contraindications for placement of esophageal balloon manometry, for example hypoglycemia managed with extended feeding times greater than 30 minutes. * neonates with contraindications for electrical impedance tomography, for example inability to ensure contact of the electrodes on the belt with the skin on the circumference of the chest due to presence of a chest tube dressing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in electrical impedance | 2.5 hours during the lung physiology assessment | change in average electrical impedance with each CPAP delivery modality |
| duration of CPAP treatment | through study completion, an average of 2 weeks after the lung physiology assessment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) tidal volume | 2.5 hours during the lung physiology assessment | tidal volume (in milliliters) per weight (in kilograms) |
| lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in minute ventilation | 2.5 hours during the lung physiology assessment | change in minute ventilation (mL/minute) |
| lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in dynamic compliance | 2.5 hours during the lung physiology assessment | change in dynamic compliance (mL/cmH2O) |
| lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Respiratory rate | 2.5 hours during the lung physiology assessment | Respiratory rate (breaths per minute) |
| lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Oxygen saturation | 2.5 hours during the lung physiology assessment | Oxygen saturation (percentage) |
| lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Abdominal circumference | 2.5 hours during the lung physiology assessment | Abdominal circumference (cm) |
| lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in end expiratory lung impedance | 2.5 hours during the lung physiology assessment | change in end expiratory lung impedance (arbitrary units) |
| lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) end expiratory pressure | 2.5 hours during the lung physiology assessment | end expiratory pressure via esophageal balloon manometry (mm Hg) |
| lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) pressure rate product | 2.5 hours during the lung physiology assessment | pressure rate product (cm H2O / min) |
| clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) Frequency of deviation | through study completion, an average of 2 weeks after the lung physiology assessment | frequency of deviation from assigned CPAP treatment (percentage) |
| clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) frequency of exogenous surfactant administration | through study completion, an average of 2 weeks after the lung physiology assessment | frequency of exogenous surfactant administration (percentage) |
| clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) | through study completion, an average of 2 weeks after the lung physiology assessment | respiratory support settings if deviated from assigned CPAP treatment (percentage) |
| lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) esophageal pressure change | 2.5 hours during the lung physiology assessment | esophageal pressure change (mm Hg) |
| lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) vascular pulsatility | 2.5 hours during the lung physiology assessment | vascular pulsatility (arbitrary units) |
Countries
United States
Outcome results
None listed