Comparison of High Flow Nasal Cannula Therapy to Nasal Oxygen as a Treatment for Obstructive Sleep Apnea in Infants
1 other identifier
interventional
9
1 country
2
Brief Summary
This is a small pilot study that will compare High Flow Nasal Cannula (HFNC) therapy to oxygen nasal cannula therapy on infants who have obstructive sleep apnea (OSA) and are scheduled for a clinically ordered sleep study called polysomnography (PSG). The HFNC procedure uses humidified room air delivered by nasal cannula at higher pressures and will test if HFNC can control OSA in infants better or as well as low flow nasal oxygen, the current clinical standard of care. All the infants in the study will have a brief test period of about 3 to 4 hours with the HFNC before participants begin their standard clinical PSG for titration of oxygen by nasal cannula for treatment of OSA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2016
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 25, 2016
CompletedFirst Posted
Study publicly available on registry
August 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2021
CompletedResults Posted
Study results publicly available
August 23, 2021
CompletedMarch 15, 2022
March 1, 2022
5.5 years
July 25, 2016
June 4, 2021
March 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Average AHI Diagnostic Sleep Study Compared to Average AHI With Improvement in OSA With HFNC
AHI will be compared from diagnostic sleep study to average AHI with improvement in OSA with HFNC
End of visit (12 hours)
AHI From Diagnostic Sleep Study Compared to AHI From Sleep Study Improvement in OSA With Low Flow Oxygen Via Nasal Cannula
All subjects will receive 3-4 hours of experimental treatment (HFNC) during a research portion of a PSG and then for the 6-8 hours of clinically ordered PSG will receive low flow oxygen by nasal cannula.
end of visit (12 hours)
Study Arms (1)
HFNC and low flow oxygen by nasal cannula
OTHERAll subjects will receive 3-4 hours of experimental treatment (HFNC) during a research portion of a PSG and then for the 6-8 hours of clinically ordered PSG will receive active comparator (low flow oxygen by nasal cannula)
Interventions
All subjects will have a 3-4 hour intervention of HFNC to test effectiveness and safety for treating OSA
All subjects will have a 6 to 8 hours intervention during the clinically scheduled PSG of titration of oxygen by nasal cannula (standard of care) to manage sleep apnea
Eligibility Criteria
You may qualify if:
- Infants ≤ 12 months
- Diagnosis of OSA from previous PSG
You may not qualify if:
- Infants who on previous PSG had central apneas \> 50% of the AHI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Children's Mercy Hospital
Kansas City, Kansas, 64108, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Related Publications (3)
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.
PMID: 11331690BACKGROUNDKotecha SJ, Adappa R, Gupta N, Watkins WJ, Kotecha S, Chakraborty M. Safety and Efficacy of High-Flow Nasal Cannula Therapy in Preterm Infants: A Meta-analysis. Pediatrics. 2015 Sep;136(3):542-53. doi: 10.1542/peds.2015-0738. Epub 2015 Aug 17.
PMID: 26283781BACKGROUNDMilesi C, Boubal M, Jacquot A, Baleine J, Durand S, Odena MP, Cambonie G. High-flow nasal cannula: recommendations for daily practice in pediatrics. Ann Intensive Care. 2014 Sep 30;4:29. doi: 10.1186/s13613-014-0029-5. eCollection 2014.
PMID: 25593745BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Neepa Gurbani
- Organization
- Cincinnati Children's Hospital Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Neepa Gurbani, DO
Children's Hospital Medical Center, Cincinnati
- PRINCIPAL INVESTIGATOR
Zarmina Ehsan, MD
Children's Mercy Hospital Kansas City
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DO
Study Record Dates
First Submitted
July 25, 2016
First Posted
August 8, 2016
Study Start
February 1, 2016
Primary Completion
July 26, 2021
Study Completion
July 26, 2021
Last Updated
March 15, 2022
Results First Posted
August 23, 2021
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share