Comparing Different Delivery Systems of Continuous Positive Airway Pressure in Neonates

Last updated: July 3, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Trial Not Available

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Treatment

RAM cannula ventilator CPAP

Occlusive interface bubble CPAP

Clinical Study ID

NCT06038565
2023P001796
  • Ages 12-36
  • All Genders

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.

Eligibility Criteria

Inclusion

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 arereceiving 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 thesuspected diagnosis of respiratory distress syndrome

Exclusion

Exclusion Criteria:

  • neonates with congenital anomalies that potentially will affect respiratoryphysiology, for example hypoplastic lungs or gastroschisis.

  • neonates with contraindications for wearing an occlusive interface, for exampleepidermolysis bullosa which may have risk of worsening skin integrity at thepressure points of the occlusive interface, or a known small air leak that maypotentially develop into a large pneumothorax.

  • neonates with contraindications for placement of esophageal balloon manometry, forexample hypoglycemia managed with extended feeding times greater than 30 minutes.

  • neonates with contraindications for electrical impedance tomography, for exampleinability to ensure contact of the electrodes on the belt with the skin on thecircumference of the chest due to presence of a chest tube dressing.

Study Design

Treatment Group(s): 2
Primary Treatment: RAM cannula ventilator CPAP
Phase:
Study Start date:
October 18, 2023
Estimated Completion Date:
April 11, 2024

Study 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.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

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