ADINA vs. High Flow Nasal Cannula Comparison Study

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03171129

Enrollment

Registered

2017-05-31

Start date

2026-07-01

Completion date

2027-09-01

Last updated

2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Neonatal

Keywords

Respiratory Distress, Nasal CPAP, high flow nasal canula

Brief summary

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.

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.

Interventions

DEVICEAdaptive Dynamic Inspiratory Nasal Apparatus

Oxygen will be administered via ADINA

DEVICEHigh flow Nasal Canula

Oxygen will be administered via nasal canula

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

23 Weeks to 40 Weeks

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Duration of Oxygen Use	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.

Secondary

Measure	Time frame	Description
Oxygen Concentration	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.
Number of Participants with treatment-related pneumothorax	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.
Number of Participants with Excoriation at Nasal Site	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.

Countries

United States

Contacts

CONTACTTina Ramirez

TIRameriz@llu.edu909-558-5828

CONTACTAlyssa Taber

ATaber@llu.edu909-558-6087

PRINCIPAL_INVESTIGATORMitchell R Goldstein, MD

Loma Linda University Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026