Comparing Different Delivery Systems of Continuous Positive Airway Pressure in Neonates

July 3, 2024 updated by: Jessica E Shui, MD, Massachusetts General Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-1"

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
Device: RAM cannula ventilator CPAP
RAM cannula ventilator CPAP
Experimental: Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-2"

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
Device: Occlusive interface bubble CPAP
Occlusive interface bubble CPAP
Active Comparator: Randomization to standard of care - a 'one size fits all' approach. "Arm B-1"

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
Device: RAM cannula ventilator CPAP
RAM cannula ventilator CPAP
Active Comparator: Randomization to standard of care - a 'one size fits all' approach. "Arm B-2"

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
Device: Occlusive interface bubble CPAP
Occlusive interface bubble CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in electrical impedance
Time Frame: 2.5 hours during the lung physiology assessment
change in average electrical impedance with each CPAP delivery modality
2.5 hours during the lung physiology assessment
duration of CPAP treatment
Time Frame: 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
through study completion, an average of 2 weeks after the lung physiology assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in end expiratory lung impedance
Time Frame: 2.5 hours during the lung physiology assessment
change in end expiratory lung impedance (arbitrary units)
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
Time Frame: 2.5 hours during the lung physiology assessment
vascular pulsatility (arbitrary units)
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
Time Frame: 2.5 hours during the lung physiology assessment
tidal volume (in milliliters) per weight (in kilograms)
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
Time Frame: 2.5 hours during the lung physiology assessment
change in minute ventilation (mL/minute)
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
Time Frame: 2.5 hours during the lung physiology assessment
change in dynamic compliance (mL/cmH2O)
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
Time Frame: 2.5 hours during the lung physiology assessment
Respiratory rate (breaths per minute)
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
Time Frame: 2.5 hours during the lung physiology assessment
Oxygen saturation (percentage)
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
Time Frame: 2.5 hours during the lung physiology assessment
Abdominal circumference (cm)
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
Time Frame: 2.5 hours during the lung physiology assessment
esophageal pressure change (mm Hg)
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
Time Frame: 2.5 hours during the lung physiology assessment
end expiratory pressure via esophageal balloon manometry (mm Hg)
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
Time Frame: 2.5 hours during the lung physiology assessment
pressure rate product (cm H2O / min)
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
Time Frame: through study completion, an average of 2 weeks after the lung physiology assessment
frequency of deviation from assigned CPAP treatment (percentage)
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
Time Frame: through study completion, an average of 2 weeks after the lung physiology assessment
frequency of exogenous surfactant administration (percentage)
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)
Time Frame: through study completion, an average of 2 weeks after the lung physiology assessment
respiratory support settings if deviated from assigned CPAP treatment (percentage)
through study completion, an average of 2 weeks after the lung physiology assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Jessica E Shui, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2023

Primary Completion (Actual)

April 11, 2024

Study Completion (Actual)

April 11, 2024

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

July 3, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023P001796

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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