Clinical trial NCT03171129: ADINA vs. High Flow Nasal Cannula Comparison Study
Official title: Adaptive Dynamic Inspiratory Nasal Apparatus (ADINA): Comparison to High Flow Nasal Cannula (HFNC)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiratory Distress Neonatal
Keywords: Respiratory Distress
Nasal CPAP
high flow nasal canula
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 23
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of Oxygen Use
timeFrame: From time of randomization until time of discharge from the Neonatal Intensive Care Unit (NICU) up to 100 days.
Secondary outcomes:
measure: Oxygen Concentration
timeFrame: From time of randomization until time of discharge from NICU up to 100 days.
measure: Number of Participants with treatment-related pneumothorax
timeFrame: From time of randomization until time of discharge from NICU up to 100 days.
measure: Number of Participants with Excoriation at Nasal Site
timeFrame: From time of randomization until time of discharge from NICU up to 100 days.
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Loma Linda University Health
name: Mitchell R Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.