Maximizing the stability of oxygen delivered via nasal cannula.
D A Benaron, W E Benitz
https://pubmed.ncbi.nlm.nih.gov/8130865/Actively Recruiting
Led by University of Arkansas · Updated on 2026-06-30
10
Participants Needed
2
Research Sites
26 weeks
Total Duration
This research aims to better understand how nasal continuous positive airway pressure nCPAP, a common breathing support method, delivers oxygen to preterm infants born before 35 weeks gestation. The study focuses on babies with respiratory distress syndrome or respiratory distress of the newborn who are on nCPAP, investigating how much oxygen actually reaches the babys airway compared to the amount set on the device. This is important to ensure infants receive the right oxygen amount for their health. The study involves placing a small catheter in the infants oropharynx to measure the oxygen delivered directly and wrapping soft electrical impedance tomography EIT bands around the infants chest to monitor lung expansion. These measurements are taken while the infant is receiving nCPAP with an oxygen concentration between 22% and 40% and stable on any pressure level. The study collects data over a 30-minute period to capture oxygen delivery and continuous lung volume changes. Participants will have these special measurements taken during the study session without altering their ongoing treatment. Researchers will sample oxygen at three separate points within the 30-minute timeframe and continuously monitor lung volume throughout. The study tracks how effectively oxygen is delivered and how the lungs expand while on nCPAP. Study participation lasts only as long as the measurement session, with no long-term interventions or treatments required.
CONDITIONS
How Different Levels of CPAP Affect Oxygen Delivery and Lung Expansion in Preterm Infants
N
Nicholas A Rowley, MD
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University of Arkansas
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | nCPAP with investigational measurement | Routine monitoring in neonatal care |
|---|---|---|
| What it is | Investigational measurement of oxygen delivery and lung expansion in preterm infants stable on nCPAP using an oropharyngeal catheter for oxygen sampling and soft chest bands for electrical impedance tomography (EIT) lung volume assessment. | Routine clinical monitoring in neonatal care typically includes pulse oximetry for oxygen delivery assessment, clinical observation for respiratory distress, and conventional imaging (such as chest X-ray) for lung expansion evaluation. |
| Primary use | To directly measure inspired oxygen and continuous lung volume in preterm infants on nCPAP using targeted sampling and real-time EIT imaging. | Monitor oxygen delivery and lung expansion using pulse oximetry and clinical observation; conventional imaging supports diagnosis and routine care where indicated. |
| How it is given or performed | Participants receive nCPAP as standard practice; during the study, an oropharyngeal catheter is placed for brief oxygen sampling, and EIT bands are wrapped around the chest for continuous lung volume measurement over 30 minutes. | Routine monitoring involves pulse oximetry sensors continuously measuring oxygen saturation, clinical staff observation, and conventional imaging (such as chest X-ray) performed when clinically indicated. |
| Evidence status | No clinical outcome evidence yet posted for this protocol in the trial registry; ongoing trial aims to generate direct evidence for investigational measurements. | Routine pulse oximetry and clinical observation are supported by systematic review and meta-analysis as effective tools for monitoring oxygen delivery in preterm infants on noninvasive respiratory support. |
| Important limitations | The investigational approach requires additional instrumentation (catheter, EIT bands), may cause minor discomfort, and is limited to a short study window; lacks established clinical outcome data. | Routine monitoring techniques provide indirect measurement of lung expansion and may not detect rapid changes in lung volume; chest imaging involves radiation and is not continuous. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 30 minutes
Participants will have a catheter placed in their oropharynx and soft bands placed around their chest to measure oxygen delivery and lung expansion while on nasal CPAP.
Single session
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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D A Benaron, W E Benitz
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https://pubmed.ncbi.nlm.nih.gov/34830385/University of Arkansas
Lead Sponsor