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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02632825 |
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Date of registration:
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10/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of Nasal High Flow Therapy on Ventilation and Gas Exchange in Healthy Newborns
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Scientific title:
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Effects of Nasal High Flow Therapy on Ventilation and Gas Exchange During Wakefulness and Sleep in Healthy Newborn Babies in a Randomized Crossover Study Design |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02632825 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Armenia
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Contacts
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Name:
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Pavel Mazmanyan, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Head of Neonatal Unit of Research Centre of Maternal and Child Health |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy full or near full-term newborns of 1-2 days of age.
- A parent has given written informed consent to their baby's participation.
Exclusion Criteria:
- Infants who are clinically unstable and unsuitable for non-invasive respiratory
support as judged by consultant clinician or required supplemental oxygen.
- Known upper airway, lower respiratory tract, cardiac or gastrointestinal tract
anomaly.
- A parent has not given written informed consent.
Age minimum:
N/A
Age maximum:
3 Days
Gender:
All
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Health Condition(s) or Problem(s) studied
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Respiratory Support
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Intervention(s)
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Device: Nasal High Flow
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Primary Outcome(s)
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Change of respiratory rate
[Time Frame: Up to 1 hour]
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Change of minute ventilation
[Time Frame: Up to 1 hour]
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Secondary Outcome(s)
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Tissue carbon dioxide
[Time Frame: Up to 1 hour]
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Tissue oxygen
[Time Frame: Up to 1 hour]
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Heart rate
[Time Frame: Up to 1 hour]
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Oxygen saturation
[Time Frame: Up to 1 hour]
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Secondary ID(s)
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RCMCHP014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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