ADINA vs. High Flow Nasal Cannula Comparison Study

January 28, 2026 updated by: Loma Linda University

Adaptive Dynamic Inspiratory Nasal Apparatus (ADINA): Comparison to High Flow Nasal Cannula (HFNC)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

NCPAP has been used increasingly to manage respiratory distress in newborns as well as apnea of prematurity. Humidified high flow nasal cannula devices (flows 1-8 lpm) have also been used in neonatal intensive care units.

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 9 months (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Neonates admitted to NICU
  • Weights of 400-500 grams
  • Requiring oxygen greater than 30%
  • No evidence of focal lobar consolidation in lung fields

Exclusion Criteria:

  • Intolerance to procedure
  • gelatinous skin
  • known allergy to adhesive material
  • interference with therapy
  • profound sepsis
  • pneumonia
  • unmanaged apnea/bradycardia
  • known or suspect complex congenital heart disease
  • severe cleft lip or palate
  • suspect or proven lethal congenital anomaly
  • intolerance to the interface used in the devices
  • inability to secure an appropriate fit of the patient nasal interface
  • considered non-viable or of uncertain viability
  • parental refusal.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High flow nasal cannula system w/ ADINA
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.
Device: Adaptive Dynamic Inspiratory Nasal Apparatus
Oxygen will be administered via ADINA
Other Names:
  • ADINA
Active Comparator: high flow nasal cannula system
High flow nasal cannula will deliver oxygen at 2-4 lpm of flow. High flow cannula are used to provide the control interface.
Device: High flow Nasal Canula
Oxygen will be administered via nasal canula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Oxygen Use
Time Frame: From time of randomization until time of discharge from the Neonatal Intensive Care Unit (NICU) up to 100 days.
The length of time the patient is on oxygen will be measured in hours.
From time of randomization until time of discharge from the Neonatal Intensive Care Unit (NICU) up to 100 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen Concentration
Time Frame: From time of randomization until time of discharge from NICU up to 100 days.
ADINA will provide a concentration of oxygen between 1.5 and 4 liters which is equivalent to that provided by the conventional nasal cannula. This will be measured every twelve hours by NICU staff.
From time of randomization until time of discharge from NICU up to 100 days.
Number of Participants with treatment-related pneumothorax
Time Frame: From time of randomization until time of discharge from NICU up to 100 days.
Participants will be monitored for pneumothorax occurrence while on ADINA and/or high flow nasal cannula. The incidence of pneumothorax occurrence in each Arm will be collected for comparison.
From time of randomization until time of discharge from NICU up to 100 days.
Number of Participants with Excoriation at Nasal Site
Time Frame: From time of randomization until time of discharge from NICU up to 100 days.
Participants will be monitored for excoriation at the nasal site while on ADINA and/or high flow nasal cannula. The incidence of excoriation at the nasal site in each Arm will be collected for comparison.
From time of randomization until time of discharge from NICU up to 100 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Mitchell R Goldstein, MD, Loma Linda University Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

May 25, 2017

First Submitted That Met QC Criteria

May 26, 2017

First Posted (Actual)

May 31, 2017

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5160055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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