ADINA vs. High Flow Nasal Cannula Comparison Study

Part of paid clinical trials in Loma Linda, California.

Sponsor
Loma Linda University
Study ID
NCT03171129
Status
Not Yet Recruiting

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Conditions

  • Respiratory Distress Neonatal

Eligibility Criteria

Sex
ALL
Age
23 Weeks - 40 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Adaptive Dynamic Inspiratory Nasal Apparatus — DEVICE
    Oxygen will be administered via ADINA
  • High flow Nasal Canula — DEVICE
    Oxygen will be administered via nasal canula

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jan 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High flow nasal cannula system w/ ADINA
    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.
  • Active Comparator: high flow nasal cannula system
    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 Measure

Duration of Oxygen Use [ Time Frame: From time of randomization until time of discharge from the Neonatal Intensive Care Unit (NICU) up to 100 days. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Loma Linda University Medical CenterLoma LindaCalifornia92354-

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Loma Linda University Medical Center· Loma Linda, CA

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