Respiratory Distress Neonatal Clinical Trial
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.
| Status | Not yet recruiting |
| Enrollment | 40 |
| Est. completion date | September 2025 |
| Est. primary completion date | September 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 23 Weeks to 40 Weeks |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Loma Linda University Medical Center | Loma Linda | California |
| Lead Sponsor | Collaborator |
|---|---|
| Loma Linda University |
United States,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | |
| Secondary | 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. | |
| Secondary | 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. | From time of randomization until time of discharge from NICU up to 100 days. | |
| Secondary | 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. |