Continuous Positive Airway Pressure, Low Birth Weight Infants, Respiratory Distress Syndrome, Newborn
Conditions
Keywords
Nasal Cannula
Brief summary
The purpose of this study is to determine if the RAM cannula is as effective as conventional binasal prongs to deliver CPAP to low birth weight infants with respiratory distress.
Interventions
DEVICERAM Cannula
DEVICEBinasal Prong CPAP
Sponsors
Children's Hospitals and Clinics of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Low Birth Weight Infant * Currently on continuous positive aireway pressure of 5-7 cm water pressure * Receiving continuous positive airway pressure support for \> 24 hrs prior to enrollment * Fraction of inspired oxygen requirement of 23-50%
Exclusion criteria
* Fraction of inspired oxygen \> 50% * Congenital defects of head, pulmonary or cardiovascular systems * Chromosomal abnormalities/genetic syndromes * Invasive Surgical Procedure within 24 hrs prior to enrollment * Enrollment in separate clinical trial that has ongoing data collection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygenation | 3 hrs | Pulse oximetry |
| Ventilation | 3 hrs | transcutaneous carbon dioxide monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Esophageal pressure measurements | 3 hrs | Esophageal Pressure Catheter |
| Apnea | 3 hrs | 3-channel pneumogram |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pulse | 3 hrs | — |
| Respiratory Rate | 3 hrs | — |
| Blood Pressure | 3 hrs | — |
| Oxygen requirement | 3 hrs | Measured by fraction of inspired oxygen to maintain target pulse oximetry saturation. |
Countries
United States
Outcome results
None listed