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NCT Number: NCT03171129

ADINA vs. High Flow Nasal Cannula Comparison Study

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.

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Key information

Conditions

Respiratory Distress Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyspnea Hyaline Membrane Disease Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

23 week–40 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adaptive Dynamic Inspiratory Nasal Apparatus

Device

Oxygen will be administered via ADINA

Other names: ADINA

high flow nasal canula

Device

Oxygen will be administered via nasal canula

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alyssa Taber

CONTACT

[email protected]

909-558-6087

Tina Ramirez

CONTACT

[email protected]

909-558-5828

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 31, 2017
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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