40 Participants Needed

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

JR
MR
TR
AT
Overseen ByAlyssa Taber
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Loma Linda University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.

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 data supports the effectiveness of the treatment Adaptive Dynamic Inspiratory Nasal Apparatus (ADINA) and High Flow Nasal Cannula for breathing difficulties in premature babies?

Research shows that using a high flow nasal cannula (a tube that delivers warm, moist air through the nose) can help premature babies breathe better by improving their lung function and reducing their effort to breathe. This treatment has been effective in supporting breathing in preterm infants, especially after they have been taken off a ventilator.12345

Is the high flow nasal cannula safe for premature babies?

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 and longer hospital stays in extremely low birth weight infants.12567

How is the ADINA treatment different from other treatments for breathing difficulties in premature babies?

The Adaptive Dynamic Inspiratory Nasal Apparatus (ADINA) is unique because it adapts to the baby's breathing patterns, potentially offering more personalized support compared to the High Flow Nasal Cannula (HFNC), which provides a constant flow of air. This adaptability may help reduce the effort of breathing more effectively in premature infants.128910

Research Team

MR

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%.
See 1 more

Exclusion Criteria

Intolerance to procedure
My skin feels like gel.
Known allergy to adhesive material
See 11 more

Timeline

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

Treatment Details

Interventions

  • Adaptive Dynamic Inspiratory Nasal Apparatus
  • High flow Nasal Canula
Trial OverviewThe 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
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials
322
Recruited
267,000+

References

The Relationship between High Flow Nasal Cannula Flow Rate and Effort of Breathing in Children. [2021]
Effect of randomization of nasal high flow rate in preterm infants. [2020]
Predicting Nasal High-Flow Treatment Success in Newborn Infants with Respiratory Distress Cared for in Nontertiary Hospitals. [2021]
[Efficacy of heated humidified high-flow nasal cannula in preterm infants aged less than 32 weeks after ventilator weaning]. [2020]
Randomized controlled trial to compare sleep and wake in preterm infants less than 32weeks of gestation receiving two different modes of non-invasive respiratory support. [2015]
High Flow Nasal Cannula Use Is Associated with Increased Morbidity and Length of Hospitalization in Extremely Low Birth Weight Infants. [2018]
Risk factors for treatment failure of heated humidified high-flow nasal cannula as initial respiratory support for preterm infants. [2023]
Electrical activity of the diaphragm during nCPAP and high flow nasal cannula. [2017]
A case series of paediatric high flow nasal cannula therapy. [2013]
10.United Statespubmed.ncbi.nlm.nih.gov
High-flow nasal cannulae in very preterm infants after extubation. [2022]