NCT06038565

Comparing Different Delivery Systems of Continuous Positive Airway Pressure in Neonates

Comparing Regional Ventilation in Neonates With Different Delivery Systems of Continuous Positive Airway Pressure

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 12 Hours – 36 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Prematurity
• Respiratory Distress Syndrome

Interventions

Type	Name	Description
DEVICE	RAM cannula ventilator CPAP	RAM cannula ventilator CPAP
DEVICE	Occlusive interface bubble CPAP	Occlusive interface bubble CPAP

Timeline

• Start date: 2023-10-18
• Primary completion: 2024-04-11
• Completion: 2024-04-11
• First posted: 2023-09-15
• Last updated: 2024-07-08

Locations

1 site across 1 country: United States