Respiratory Distress NeonatalNCT03171129
ADINA vs. High Flow Nasal Cannula Comparison Study
A study testing Adaptive Dynamic Inspiratory Nasal Apparatus and High flow Nasal Canula in people with Respiratory Distress Neonatal, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 40 weeks
- Conditions the study is for
- Respiratory Distress Neonatal
- What is being tested?
- Adaptive Dynamic Inspiratory Nasal Apparatus and High flow Nasal Canula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 40 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates admitted to NICU
- Weights of 400-500 grams
- Requiring oxygen greater than 30%
- No evidence of focal lobar consolidation in lung fields
Who cannot join
- Intolerance to procedure
- gelatinous skin
- known allergy to adhesive material
- interference with therapy
- profound sepsis
- pneumonia
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
Official title: 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.
Read the 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.
- Conditions
- Respiratory Distress Neonatal
- Being tested
- Adaptive Dynamic Inspiratory Nasal Apparatus, High flow Nasal Canula
- Keywords
- Respiratory Distress, Nasal CPAP, high flow nasal canula
- Medical subject headings
- Hyaline Membrane Disease, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Dynamic Inspiratory Nasal ApparatusDevice
Also called ADINA
Oxygen will be administered via ADINA
High flow Nasal CanulaDevice
Oxygen will be administered via nasal canula
| Study group | Role | What they receive |
|---|---|---|
| High flow nasal cannula system w/ ADINA | Experimental | 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. Receives: Device: Adaptive Dynamic Inspiratory Nasal Apparatus |
| high flow nasal cannula system | Active comparator | High flow nasal cannula will deliver oxygen at 2-4 lpm of flow. High flow cannula are used to provide the control interface. Receives: Device: High flow Nasal Canula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Oxygen Use
The length of time the patient is on oxygen will be measured in hours.
Measured: From time of randomization until time of discharge from the Neonatal Intensive Care Unit (NICU) up to 100 days.
Secondary outcomes (3)
Oxygen Concentration
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.
Measured: From time of randomization until time of discharge from NICU up to 100 days.
Number of Participants with treatment-related pneumothorax
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.
Measured: From time of randomization until time of discharge from NICU up to 100 days.
Number of Participants with Excoriation at Nasal Site
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.
Measured: From time of randomization until time of discharge from NICU up to 100 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study startJul 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress NeonatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitchell R Goldstein, MD, Principal investigator, Loma Linda University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171129
- Sponsor's protocol ID
- 5160055
- Status last verified
- Jan 2026
- First submitted
- 25 May 2017
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gregory GA, Kitterman JA, Phibbs RH, Tooley WH, Hamilton WK. Treatment of the idiopathic respiratory-distress syndrome with continuous positive airway pressure. N Engl J Med. 1971 Jun 17;284(24):1333-40. doi: 10.1056/NEJM197106172842401. No abstract available.
PubMed 4930602Dutta S. High-flow nasal cannula versus nasal continuous positive airway pressure in the management of apnea of prematurity. Pediatrics. 2002 Apr;109(4):718-9; author reply 718-9. doi: 10.1542/peds.109.4.718. No abstract available.
PubMed 11927724Campbell DM, Shah PS, Shah V, Kelly EN. Nasal continuous positive airway pressure from high flow cannula versus Infant Flow for Preterm infants. J Perinatol. 2006 Sep;26(9):546-9. doi: 10.1038/sj.jp.7211561. Epub 2006 Jul 13.
PubMed 16837929Kubicka ZJ, Limauro J, Darnall RA. Heated, humidified high-flow nasal cannula therapy: yet another way to deliver continuous positive airway pressure? Pediatrics. 2008 Jan;121(1):82-8. doi: 10.1542/peds.2007-0957.
PubMed 18166560Woodhead DD, Lambert DK, Clark JM, Christensen RD. Comparing two methods of delivering high-flow gas therapy by nasal cannula following endotracheal extubation: a prospective, randomized, masked, crossover trial. J Perinatol. 2006 Aug;26(8):481-5. doi: 10.1038/sj.jp.7211543. Epub 2006 May 25.
PubMed 16724119Shoemaker MT, Pierce MR, Yoder BA, DiGeronimo RJ. High flow nasal cannula versus nasal CPAP for neonatal respiratory disease: a retrospective study. J Perinatol. 2007 Feb;27(2):85-91. doi: 10.1038/sj.jp.7211647.
PubMed 17262040Sreenan C, Lemke RP, Hudson-Mason A, Osiovich H. High-flow nasal cannulae in the management of apnea of prematurity: a comparison with conventional nasal continuous positive airway pressure. Pediatrics. 2001 May;107(5):1081-3. doi: 10.1542/peds.107.5.1081.
PubMed 11331690Centers for Disease Control and Prevention (CDC). Update: Ralstonia species associated with Vapotherm oxygen delivery devices--United States, 2005. MMWR Morb Mortal Wkly Rep. 2005 Nov 4;54(43):1104-5.
PubMed 16267498Centers for Disease Control and Prevention (CDC). Ralstonia associated with Vapotherm oxygen delivery device--United States, 2005. MMWR Morb Mortal Wkly Rep. 2005 Oct 21;54(41):1052-3.
PubMed 16237377
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Dynamic Inspiratory Nasal Apparatus (ADINA): Comparison to High Flow Nasal Cannula (HFNC)
- ClinicalTrials.gov ID
- NCT03171129
- Acronym / sponsor ID
- 5160055
- Conditions
- Respiratory Distress Neonatal
- Keywords
- Respiratory Distress, Nasal CPAP, high flow nasal canula
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow nasal cannula system w/ ADINA | Experimental | Device: Adaptive Dynamic Inspiratory Nasal ApparatusThe 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. |
| high flow nasal cannula system | Active comparator | Device: High flow Nasal CanulaHigh flow nasal cannula will deliver oxygen at 2-4 lpm of flow. High flow cannula are used to provide the control interface. |
Who may qualify
- Ages
- 23 to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Neonates admitted to NICU
- Weights of 400-500 grams
- Requiring oxygen greater than 30%
- No evidence of focal lobar consolidation in lung fields
Key exclusion criteria (14 listed)
- Intolerance to procedure
- gelatinous skin
- known allergy to adhesive material
- interference with therapy
- profound sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive Dynamic Inspiratory Nasal ApparatusAlso: ADINAOxygen will be administered via ADINA | Device | High flow nasal cannula system w/ ADINA |
| High flow Nasal CanulaOxygen will be administered via nasal canula | Device | high flow nasal cannula system |
Primary outcome
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.
3 secondary outcomes
Oxygen Concentration
Time frame: 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.
Number of Participants with Excoriation at Nasal Site
Time frame: From time of randomization until time of discharge from NICU up to 100 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Background: PubMed 4930602Gregory GA, Kitterman JA, Phibbs RH, Tooley WH, Hamilton WK. Treatment of the idiopathic respiratory-distress syndrome with continuous positive airway pressure. N Engl J Med. 1971 Jun 17;284(24):1333-40. doi: 10.1056/NEJM197106172842401. No abstract available.
- Background: PubMed 11927724Dutta S. High-flow nasal cannula versus nasal continuous positive airway pressure in the management of apnea of prematurity. Pediatrics. 2002 Apr;109(4):718-9; author reply 718-9. doi: 10.1542/peds.109.4.718. No abstract available.
- Background: PubMed 16837929Campbell DM, Shah PS, Shah V, Kelly EN. Nasal continuous positive airway pressure from high flow cannula versus Infant Flow for Preterm infants. J Perinatol. 2006 Sep;26(9):546-9. doi: 10.1038/sj.jp.7211561. Epub 2006 Jul 13.
- Background: PubMed 18166560Kubicka ZJ, Limauro J, Darnall RA. Heated, humidified high-flow nasal cannula therapy: yet another way to deliver continuous positive airway pressure? Pediatrics. 2008 Jan;121(1):82-8. doi: 10.1542/peds.2007-0957.
- Background: PubMed 16724119Woodhead DD, Lambert DK, Clark JM, Christensen RD. Comparing two methods of delivering high-flow gas therapy by nasal cannula following endotracheal extubation: a prospective, randomized, masked, crossover trial. J Perinatol. 2006 Aug;26(8):481-5. doi: 10.1038/sj.jp.7211543. Epub 2006 May 25.
- Background: PubMed 17262040Shoemaker MT, Pierce MR, Yoder BA, DiGeronimo RJ. High flow nasal cannula versus nasal CPAP for neonatal respiratory disease: a retrospective study. J Perinatol. 2007 Feb;27(2):85-91. doi: 10.1038/sj.jp.7211647.
- Background: PubMed 11331690Sreenan C, Lemke RP, Hudson-Mason A, Osiovich H. High-flow nasal cannulae in the management of apnea of prematurity: a comparison with conventional nasal continuous positive airway pressure. Pediatrics. 2001 May;107(5):1081-3. doi: 10.1542/peds.107.5.1081.
- Background: PubMed 16267498Centers for Disease Control and Prevention (CDC). Update: Ralstonia species associated with Vapotherm oxygen delivery devices--United States, 2005. MMWR Morb Mortal Wkly Rep. 2005 Nov 4;54(43):1104-5.
- Background: PubMed 16237377Centers for Disease Control and Prevention (CDC). Ralstonia associated with Vapotherm oxygen delivery device--United States, 2005. MMWR Morb Mortal Wkly Rep. 2005 Oct 21;54(41):1052-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mitchell R Goldstein, MD principal investigator
Loma Linda University Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Dynamic Inspiratory Nasal Apparatus and High flow Nasal Canula in people with Respiratory Distress Neonatal, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tina Ramirez (909-558-5828, TIRameriz@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03171129, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.