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Comparing Different Delivery Systems of Continuous Positive Airway Pressure in Neonates

NCT06038565 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-07-08

No results posted yet for this study

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.

Conditions

  • Prematurity
  • Respiratory Distress Syndrome

Interventions

DEVICE

RAM cannula ventilator CPAP

RAM cannula ventilator CPAP

DEVICE

Occlusive interface bubble CPAP

Occlusive interface bubble CPAP

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Jessica E Shui, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Hours
Max Age
36 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2024-04-11
Completion
2024-04-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06038565 on ClinicalTrials.gov