Respiratory Distress NeonatalNewbornChildren's healthDevice
What this study is
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.
What's being tested
- Adaptive Dynamic Inspiratory Nasal Apparatus
Intervention · DEVICE
Oxygen will be administered via ADINA
- High flow Nasal Canula
Intervention · DEVICE
Oxygen will be administered via nasal canula
Study details
- Official title
- Adaptive Dynamic Inspiratory Nasal Apparatus (ADINA): Comparison to High Flow Nasal Cannula (HFNC)
- Sponsor
- Loma Linda University
- Conditions
- Respiratory Distress Neonatal
- Enrolling
- 40 people
- Starts
- 2026-07
- Est. completion
- 2027-09
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 23 Weeks – 40 WeeksSex ALLHealthy volunteers Not acceptedYou may qualify if
- Neonates admitted to NICU
- Weights of 400-500 grams
- Requiring oxygen greater than 30%
- No evidence of focal lobar consolidation in lung fields
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openLoma Linda University Medical Center
Loma Linda, California, United States
Study team
Sponsor
Loma Linda University
Study ID 5160055
Principal investigator
Mitchell R Goldstein, MD
Loma Linda University Health
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.