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Respiratory Support Device

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

N/A

Waitlist Available

Led By Mitchell R Goldstein, MD

Research Sponsored by Loma Linda University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Requiring oxygen greater than 30%

Neonates admitted to NICU

Must not have

Gelatinous skin

Profound sepsis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of randomization until time of discharge from nicu up to 100 days.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a pressure-limited nasal cannula can be used instead of a high-flow nasal cannula to help premature babies with breathing difficulties.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include discomfort from wearing the devices, skin irritation due to adhesive materials used to secure them, and potential intolerance leading to discontinuation of use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need oxygen support of more than 30%.

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My newborn is in the neonatal intensive care unit.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My skin feels like gel.

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I am currently suffering from a severe infection.

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I have or might have a complex heart condition present from birth.

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I have pneumonia.

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I have uncontrolled sleep apnea or slow heart rate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of randomization until time of discharge from nicu up to 100 days.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of randomization until time of discharge from nicu up to 100 days.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of randomization until time of discharge from nicu up to 100 days. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Duration of Oxygen Use

Secondary study objectives

Number of Participants with Excoriation at Nasal Site

Number of Participants with treatment-related pneumothorax

Oxygen Concentration

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High flow nasal cannula system w/ ADINAExperimental Treatment1 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 systemActive Control1 Intervention

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

0 / 7Eligibility criteria met