Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of randomization until time of discharge from nicu up to 100 days.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I need oxygen support of more than 30%.
Select...
My newborn is in the neonatal intensive care unit.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of Oxygen Use
Secondary outcome measures
Number of Participants with Excoriation at Nasal Site
Number of Participants with treatment-related pneumothorax
Oxygen Concentration
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.
Find a Location
Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
306 Previous Clinical Trials
260,948 Total Patients Enrolled
4 Trials studying Respiratory Distress Syndrome
235 Patients Enrolled for Respiratory Distress Syndrome
Mitchell R Goldstein, MDPrincipal InvestigatorLoma Linda University Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My skin feels like gel.I am currently suffering from a severe infection.I have or might have a complex heart condition present from birth.My condition is considered not likely to improve.I need oxygen support of more than 30%.I have pneumonia.I have uncontrolled sleep apnea or slow heart rate.My newborn is in the neonatal intensive care unit.
Research Study Groups:
This trial has the following groups:- Group 1: High flow nasal cannula system w/ ADINA
- Group 2: high flow nasal cannula system
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Which individuals are acceptable candidates for this experiment?
"This experiment is enrolling neonates, between 23 and 40 Weeks of age who have been admitted to the Neonatal ICU with respiratory distress. To be eligible for participation, patients must weigh 400-500 grams and require oxygen supplementation greater than 30%. In addition, there can be no evidence of localized lung pathology."
Answered by AI
Is eligibility for this trial restricted to those under 70 years of age?
"This trial is accepting patients aged between 23 and 40 weeks, as mandated by the eligibility criteria."
Answered by AI
Are there still spots available in this clinical trial for participants?
"Per the information on clinicaltrials.gov, this research is not presently recruiting patients. The trial was first published in November 1st 2022 and last revised July 15th 2022. However, 3 other medical studies are actively enrolling volunteers at present."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger