Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2026-07-31
2027-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Adaptive Dynamic Inspiratory Nasal Apparatus
Oxygen will be administered via ADINA
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.
High flow Nasal Canula
Oxygen will be administered via nasal canula
Interventions
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Adaptive Dynamic Inspiratory Nasal Apparatus
Oxygen will be administered via ADINA
High flow Nasal Canula
Oxygen will be administered via nasal canula
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Weights of 400-500 grams
* Requiring oxygen greater than 30%
* No evidence of focal lobar consolidation in lung fields
Exclusion Criteria
* 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.
23 Weeks
40 Weeks
ALL
No
Sponsors
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Loma Linda University
OTHER
Responsible Party
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Principal Investigators
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Mitchell R Goldstein, MD
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University Health
Locations
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Loma Linda University Medical Center
Loma Linda, California, United States
Countries
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Central Contacts
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References
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Sreenan 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.
Centers 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.
Centers 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.
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.
Dutta 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.
Campbell 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.
Kubicka 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.
Woodhead 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.
Shoemaker 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.
Other Identifiers
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5160055
Identifier Type: -
Identifier Source: org_study_id
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