Comparing Different Delivery Systems of Continuous Positive Airway Pressure in Neonates

Mass General Brigham

Status: Withdrawn

Conditions: Prematurity; Respiratory Distress Syndrome

Treatments: Device: RAM cannula ventilator CPAP; Device: Occlusive interface bubble CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT06038565

2023P001796

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 12 to 36 hours old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 4 patient groups

Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-1"

Experimental group

Description:

After comparing change of impedance as measured by electrical impedance tomography while supported on RAM cannula ventilator CPAP versus occlusive interface bubble CPAP, the participants in this arm are placed on the CPAP that had a greater change of impedance (or less pressure rate product as measured by the esophageal balloon manometry if the change of impedance between the two CPAP modalities are clinically similar). In this Arm A-1, these subjects had higher change in impedance while supported on RAM cannula ventilator CPAP

Treatment:

Device: RAM cannula ventilator CPAP

Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-2"

Experimental group

Description:

After comparing change of impedance as measured by electrical impedance tomography while supported on RAM cannula ventilator CPAP versus occlusive interface bubble CPAP, the participants in this arm are placed on the CPAP that had a greater change of impedance (or less pressure rate product as measured by the esophageal balloon manometry if the change of impedance between the two CPAP modalities are clinically similar). In this Arm A-2, these subjects had higher change in impedance while supported on occlusive mask bubble CPAP

Treatment:

Device: Occlusive interface bubble CPAP

Randomization to standard of care - a 'one size fits all' approach. "Arm B-1"

Active Comparator group

Description:

Currently, the approach to which CPAP modality is chosen for these newborns is defaulted to the preferred CPAP of the Neonatal Intensive Care Unit (NICU) where the newborn is hospitalized. In this Arm B-1, these subjects are randomized 1:1 to RAM cannula ventilator CPAP

Treatment:

Device: RAM cannula ventilator CPAP

Randomization to standard of care - a 'one size fits all' approach. "Arm B-2"

Active Comparator group

Description:

Currently, the approach to which CPAP modality is chosen for these newborns is defaulted to the preferred CPAP of the NICU where the newborn is hospitalized. In this Arm B-2, these subjects are randomized 1:1 to occlusive mask bubble CPAP

Treatment:

Device: Occlusive interface bubble CPAP