Respiratory Distress of Newborn, Respiratory Distress Syndrome (Neonatal)
Conditions
Keywords
respiratory distress syndrome, CPAP, preterm infant, effective oxygen delivery
Brief summary
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.
Detailed description
This study will tell more about a specific method of breathing support used frequently with preterm babies called nasal continuous positive airway pressure (nCPAP). It helps the baby breathe by providing air pressure and a certain amount of oxygen. It is very important for the baby's health to provide only as much oxygen as they need. With this study, it is expected to learn if the amount of oxygen ordered by a doctor on the nCPAP machine changes when it reaches the baby's airway, and if the amount of oxygen changes depending on how much air pressure the doctor provides. The answers to these questions, are not known, because special measurements are required that are difficult to know while a baby is on nCPAP. This study will collect these special measurements
Interventions
DEVICEEffective oxygen delivery and lung expansion measurement
This 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.
Sponsors
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inspired Oxygen | Sampling will occur at three separate points within a thirty minute time frame for each enrolled infant. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung Volume | Long volume will be continuously monitored throughout the 30 minute duration of the study for each enrolled infant. | 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. |
Countries
United States
Contacts
CONTACTNicholas A Rowley, MD
Outcome results
None listed