RecruitingACTRN12624001314516

Airway pressure measurements in newborns on non-invasive respiratory support: a feasibility study (AIRPREMO 2 Study)

Pharyngeal pressure in newborns on non-invasive respiratory support: a feasibility study to assess a new airway pressure monitor (AIRPREMO 2 Feasibility Study)


Sponsor

The Royal Women's Hospital Melbourne

Enrollment

50 participants

Start Date

Jan 15, 2025

Study Type

Interventional

Conditions

Summary

While continuous positive airway pressure (CPAP) and high flow nasal cannula (HFNC) are commonly used for treatment of infants with respiratory distress, the optimal level of CPAP/HFNC remains somewhat uncertain. Due to leaks occurring at the nostrils, the mouth and into the stomach, not all of the pressure generated by CPAP/HFNC is transmitted to the airway. Continuous measurement of the patient’s pharyngeal pressure could provide clinicians with important information. The proposed research is a feasibility study to measure the pharyngeal pressure in a convenience sample of up to 50 infants receiving CPAP/HFNC for the purpose of confirming the performance and safety of a new airway monitoring device. TGA-approved dual lumen gastric tubes will be modified to allow for airway pressure measurements in the pharyngeal region using a new airway pressure device (under development). The modified gastric tube will be used similar to regular gastric tubes, and pharyngeal pressures recorded over a 3-8 day period. The modified gastric tube will enable study participants to be fed as per usual clinical guidelines and facilitate enteral fluids/medication delivery as clinically required.


Eligibility

Sex: Both males and femalesMin Age: 0 DayssMax Age: 1 Years

Plain Language Summary

Simplified for easier understanding

Premature babies often need help breathing, and two common forms of support are CPAP (continuous positive airway pressure) and high-flow nasal cannula (HFNC). These treatments work by providing gentle pressure to keep the tiny airways open. However, some of that pressure is lost through leaks at the nose and mouth, so it is difficult to know exactly how much pressure actually reaches the baby's airway. Measuring this 'pharyngeal pressure' more directly could help doctors fine-tune treatment. This feasibility study is testing a modified feeding tube that has been adapted to also measure airway pressure in the throat, alongside a new pressure monitoring device. Babies who already need a feeding tube as part of their care can have this modified tube used instead, with pressure measured over several days. The study will check that the device is safe and works as intended. Your baby may be eligible if they are admitted to the Royal Women's Hospital Neonatal Intensive Care Unit, weigh at least 1 kilogram, are receiving CPAP or high-flow support, and already need a feeding tube as part of their medical care. Babies with structural abnormalities of the nose or throat are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

In the AIRPREMO 2 Study, a modified TGA-approved dual-lumen gastric tube connected to a new external device will be used to measure the upper airway pressure (pharyngeal pressure) in newborns receivin

In the AIRPREMO 2 Study, a modified TGA-approved dual-lumen gastric tube connected to a new external device will be used to measure the upper airway pressure (pharyngeal pressure) in newborns receiving non-invasive respiratory support (continuous positive airway pressure (CPAP) or high flow nasal cannula (HF)). Once inserted, the sensor lumen of the study feeding tube will be connected to a study sensor module unit which is connected to the study data acquisition unit (airway pressure monitor) that is positioned at the bedside. Pharyngeal pressure measurements will be obtained with the research data collection system for 3-8 days, with the data obtained from the study informing the development of a new device. Clinical staff will not have the ability to view the airway pressure data on the data acquisition unit unless shown by the research team. The primary feeding lumen of the gastric tube will enable study participants to be fed as per usual clinical guidelines and facilitate enteral fluids/medication delivery as clinically required. The duration of recoding can vary from 3 to 8 days as outlined in our research protocol and as per clinical practices for replacement of tubes. Enteral feeds for infants on respiratory support are administered intermittently and advance (in volume and frequency) as the infant’s tolerance of feeding increases.


Locations(1)

The Royal Women's Hospital - Parkville

VIC, Australia

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ACTRN12624001314516


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