An interventional study of Adaptive Dynamic Inspiratory Nasal Apparatus and High flow Nasal Canula in Respiratory Distress Neonatal, sponsored by Loma Linda University. Not yet recruiting at 1 site in United States. Open to participants aged 23 Weeks to 40 Weeks. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Loma Linda University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
Device: Adaptive Dynamic Inspiratory Nasal Apparatus
High flow nasal cannula will deliver oxygen at 2-4 lpm of flow. High flow cannula are used to provide the control interface.
Device: High flow Nasal Canula
Oxygen will be administered via ADINA
Also known as: ADINA
Oxygen will be administered via nasal canula
Duration of Oxygen Use
The length of time the patient is on oxygen will be measured in hours.
Time frame: From time of randomization until time of discharge from the Neonatal Intensive Care Unit (NICU) up to 100 days.
Oxygen Concentration
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.
Time frame: From time of randomization until time of discharge from NICU up to 100 days.
Number of Participants with treatment-related pneumothorax
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.
Time frame: From time of randomization until time of discharge from NICU up to 100 days.
Number of Participants with Excoriation at Nasal Site
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.
Time frame: From time of randomization until time of discharge from NICU up to 100 days.
Plan to share: No
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Loma Linda University