ADINA vs. High Flow Nasal Cannula for Breathing Difficulties in Premature Babies

Overseen by Mitchell R Goldstein, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Loma Linda University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Mitchell R Goldstein, MD

Principal Investigator

Loma Linda University Health

Eligibility Criteria

This trial is for premature babies in the NICU, weighing 400-500 grams and needing extra oxygen. It's not for those with heart issues, allergies to adhesives, severe facial deformities, infections like pneumonia or sepsis, very fragile skin, or uncontrolled breathing problems.

Inclusion Criteria

Weights of 400-500 grams

No evidence of focal lobar consolidation in lung fields

I need oxygen support of more than 30%.

Exclusion Criteria

Intolerance to procedure

My skin feels like gel.

Known allergy to adhesive material

Treatment Details

Interventions

• Adaptive Dynamic Inspiratory Nasal Apparatus (Respiratory Support Device)
• High flow Nasal Canula (Respiratory Support Device)

Trial Overview The study compares two ways of giving extra oxygen: a new method called Adaptive Dynamic Inspiratory Nasal Apparatus (ADINA) versus the usual High Flow Nasal Cannula (HFNC). The goal is to see if ADINA works better for these tiny patients.

Participant Groups

Group I: High flow nasal cannula system w/ ADINA Experimental Treatment 1 Intervention

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.

Group II: high flow nasal cannula system Active Control 1 Intervention

High flow nasal cannula will deliver oxygen at 2-4 lpm of flow. High flow cannula are used to provide the control interface.

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Adrian Cotton

Loma Linda University

Chief Medical Officer since 2020

MD

Richard H. Hart

Loma Linda University

Chief Executive Officer since 2015

MD, DrPH