ADINA vs. High Flow Nasal Cannula Comparison Study
- Conditions
- Respiratory Distress Neonatal
- Interventions
- Device: Adaptive Dynamic Inspiratory Nasal ApparatusDevice: High flow Nasal Canula
- Registration Number
- NCT03171129
- Lead Sponsor
- Loma Linda University
- Brief Summary
This study is to evaluate the feasibility of using a pressure limited nasal cannula system instead of a high flow nasal cannula system in the management of premature babies with respiratory distress.
- Detailed Description
NCPAP has been used increasingly to manage respiratory distress in newborns as well as apnea of prematurity. Humidified high flow nasal cannula devices (flows 1-8 lpm) have also been used in neonatal intensive care units.
This study is to evaluate the feasibility of using a pressure limited nasal cannula system instead of a high flow nasal cannula system in the management of premature babies with respiratory distress.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Neonates admitted to NICU
- Weights of 400-500 grams
- Requiring oxygen greater than 30%
- No evidence of focal lobar consolidation in lung fields
- Intolerance to procedure
- gelatinous skin
- known allergy to adhesive material
- interference with therapy
- profound sepsis
- pneumonia
- unmanaged apnea/bradycardia
- known or suspect complex congenital heart disease
- severe cleft lip or palate
- suspect or proven lethal congenital anomaly
- intolerance to the interface used in the devices
- inability to secure an appropriate fit of the patient nasal interface
- considered non-viable or of uncertain viability
- parental refusal.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High flow nasal cannula system w/ ADINA Adaptive Dynamic Inspiratory Nasal Apparatus The intervention is the insertion of the the ADINA device into the high flow nasal cannula system. ADINA will be placed according to weight class recommendations to increase the positive end expiratory pressure (PEEP). ADINA is actually a combination of the Neotech RAM Cannula and a clear Regulator/Pop off valve. high flow nasal cannula system High flow Nasal Canula High flow nasal cannula will deliver oxygen at 2-4 lpm of flow. High flow cannula are used to provide the control interface.
- Primary Outcome Measures
Name Time Method Duration of Oxygen Use From time of randomization until time of discharge from the Neonatal Intensive Care Unit (NICU) up to 100 days. The length of time the patient is on oxygen will be measured in hours.
- Secondary Outcome Measures
Name Time Method Number of Participants with Excoriation at Nasal Site From time of randomization until time of discharge from NICU up to 100 days. Participants will be monitored for excoriation at the nasal site while on ADINA and/or high flow nasal cannula. The incidence of excoriation at the nasal site in each Arm will be collected for comparison.
Oxygen Concentration From time of randomization until time of discharge from NICU up to 100 days. ADINA will provide a concentration of oxygen between 1.5 and 4 liters which is equivalent to that provided by the conventional nasal cannula. This will be measured every twelve hours by NICU staff.
Number of Participants with treatment-related pneumothorax From time of randomization until time of discharge from NICU up to 100 days. Participants will be monitored for pneumothorax occurrence while on ADINA and/or high flow nasal cannula. The incidence of pneumothorax occurrence in each Arm will be collected for comparison.
Trial Locations
- Locations (1)
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States