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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive Dynamic Inspiratory Nasal Apparatus | Device | Oxygen will be administered via ADINA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Oxygen Use | The length of time the patient is on oxygen will be measured in hours. | From time of randomization until time of discharge from the Neonatal Intensive Care Unit (NICU) up to 100 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From time of randomization until time of discharge from NICU up to 100 days. |
| Number of Participants with treatment-related pneumothorax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tina Ramirez | Contact | 909-558-5828 | TIRameriz@llu.edu | |
| Alyssa Taber | Contact | 909-558-6087 | ATaber@llu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mitchell R Goldstein, MD | Loma Linda University Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 4930602 | Background | 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. | |
| 11927724 | Background | 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. |
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| ID | Term |
|---|---|
| D006819 | Hyaline Membrane Disease |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| High flow Nasal Canula | Device | Oxygen will be administered via nasal canula |
|
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. |
| 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. | From time of randomization until time of discharge from NICU up to 100 days. |
| 16837929 | Background | 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. |
| 18166560 | Background | 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. |
| 16724119 | Background | 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. |
| 17262040 | Background | 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. |
| 11331690 | Background | 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. |
| 16267498 | Background | 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. |
| 16237377 | Background | 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. |
| D012120 | Respiration Disorders |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |