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

Overseen By Alyssa Taber

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Loma Linda University

Disqualifiers: Profound sepsis, Pneumonia, Complex heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 100 days

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist premature babies with breathing problems. Researchers are testing the Adaptive Dynamic Inspiratory Nasal Apparatus (ADINA) to determine if it outperforms the usual high flow nasal cannula system. Babies in the trial will either receive the ADINA device or continue with the standard high flow cannula, both designed to enhance breathing. This trial suits premature newborns in the NICU who weigh between 400-500 grams and require more than 30% oxygen to breathe. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve care for premature babies.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Adaptive Dynamic Inspiratory Nasal Apparatus is safe for premature babies?

Research shows that high flow nasal cannula systems can safely assist premature babies in breathing by delivering warm, moist air through the nose. This method is well-tolerated and considered a safe option for supporting newborns' breathing.

The Adaptive Dynamic Inspiratory Nasal Apparatus (ADINA) is a new device tested as part of this system. Specific data on ADINA's safety is limited. However, since it operates within the already safe high flow nasal cannula system, it is expected to be well-tolerated.

Overall, high flow nasal cannula systems provide a safe and effective alternative to more invasive methods like tubes inserted into the windpipe. While specific data on ADINA remains limited, its integration into a known safe system suggests promising safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Adaptive Dynamic Inspiratory Nasal Apparatus (ADINA) because it offers a fresh approach to aiding breathing in premature babies. Unlike the standard high flow nasal cannula, ADINA combines a Neotech RAM Cannula with a clear regulator/pop-off valve to adjust the pressure based on the baby's weight, potentially improving breathing efficiency. This adaptive feature could mean better support for tiny lungs, giving premature babies a gentler and more tailored breathing assistance.

What evidence suggests that the ADINA device is effective for breathing difficulties in premature babies?

This trial will compare the Adaptive Dynamic Inspiratory Nasal Apparatus (ADINA) with the standard high-flow nasal cannula system for assisting premature babies with breathing. Research suggests that ADINA may offer benefits over the standard system. The ADINA device features a special safety mechanism that adjusts airflow, potentially controlling airway pressure more effectively. High-flow nasal cannulas are commonly used and have been shown to reduce the need for more invasive breathing support and assist with respiratory distress. However, some studies suggest that using high-flow nasal cannulas alone might be associated with more health issues. ADINA aims to improve this by providing more controlled pressure, potentially offering safer and more effective breathing support for premature infants. ^{1 2 6 7 8}

Who Is on the Research Team?

Mitchell R Goldstein, MD

Principal Investigator

Loma Linda University Health

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either the ADINA device or high flow nasal cannula system for respiratory support

Up to 100 days

Continuous monitoring in NICU

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adaptive Dynamic Inspiratory Nasal Apparatus
• High flow Nasal Canula

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/phase-8-2021-4bd1e

ADINA vs. High Flow Nasal Cannula for Breathing ... High flow nasal cannula (HFNC) is generally used for breathing support in premature babies, but some studies suggest it may be linked to increased health issues ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10161968/

Nasal high flow therapy for primary respiratory support in ... The use of nHF for primary respiratory support in preterm infants of 28 weeks' gestation or greater may result in little to no difference in death or BPD, ...

3. nature.com nature.com/articles/pr2008192

Spontaneous Breathing Patterns of Very Preterm Infants ... The aim of this study was to investigate the spontaneous breathing patterns of very preterm infants treated with CPAP immediately after birth.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9371597/

High flow nasal cannula for respiratory support in preterm infants It has been shown to reduce extubation failure, treat apnoea and respiratory distress syndrome and, by minimising duration of mechanical ventilation, may reduce ...

5. researchgate.net researchgate.net/publication/51228478_High_Flow_Through_a_Nasal_Cannula_and_CPAP_Effect_in_a_Simulated_Infant_Model

(PDF) High Flow Through a Nasal Cannula and CPAP ... The ADINA (Adaptive Dynamic Inspiratory Nasal Apparatus) introduces an additional safety mechanism designed to adaptively restrict the ...

6. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006405.pub3/references

High flow nasal cannula for respiratory support in preterm ... A randomized controlled trial to compare heated humidified high‐flow nasal cannulae with nasal continuous positive airway pressure postextubation in premature ...

7. researchgate.net researchgate.net/publication/281081269_Safety_and_Efficacy_of_High-Flow_Nasal_Cannula_Therapy_in_Preterm_Infants_A_Meta-analysis

Safety and Efficacy of High-Flow Nasal Cannula Therapy in ... Results: Of the 497 infants assigned to nasal IPPV for whom adequate data were available, 191 died or survived with bronchopulmonary ...

8. ora.ox.ac.uk ora.ox.ac.uk/objects/uuid:dab0b538-c607-44b9-b748-dff9ea10a9c5/files/mbda3212816464e6eca9313eeda883480

High flow nasal cannula for respiratory support in preterm ... Nasal CPAP is widely used in premature and term newborns and provides an effective, safe alternative to endotracheal intubation. (Morley 2004). It has been ...