How Different Levels of CPAP Affect Oxygen Delivery and Lung Expansion in Preterm Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Arkansas
About this trial
With this study, it is expected to learn more about preterm babies on breathing support with nasal continuous positive airway pressure (nCPAP). To gain more information on how much oxygen is actually delivered to the baby from the nCPAP machine.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Gestational age at birth must be less than 35 weeks of completed gestation as documented in the subject's initial history and physical
The infant must be stable while receiving nasal CPAP at any pressure level at the time of study
The infant must be receiving 22-40% at the time of the study
Disqualifiers
Oxygen requirements greater than 40% at time of enrollment
currently receiving invasive ventilation or not requiring ventilatory support
Major congenital anomalies of the heart and/or lungs
Trial design
Design model
Single group
Treatments tested in this trial
Effective oxygen delivery and lung expansion measurement
DeviceThis intervention arm will involve any infant who is already on nCPAP. It will involve placing a catheter in the infant's oropharynx and wrapping soft EIT bands around the infants chest to measure effective oxygen delivery and lung expansion, respectively.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Infants on nCPAPExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Inspired Oxygen
Percent of oxygen delivered to the back of the infant's mouth. This will be measured by placing a small plastic tube in the back of the infant's mouth and sampling the air while the infant is receiving several different pressure levels of CPAP.
Time frame
Sampling will occur at three separate points within a thirty minute time frame for each enrolled infant.Secondary outcomes
1
Lung Volume
Using Electrical Impedance Tomography bands, the infant's lung volume will be monitored at several different CPAP pressure levels. These bands wrap around the infant's chest and measure lung volume using mild electrical currents.
Time frame
Long volume will be continuously monitored throughout the 30 minute duration of the study for each enrolled infant.Sponsors and contacts
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Source ClinicalTrials.gov