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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01237015 |
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Date of registration:
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08/11/2010 |
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Primary sponsor: |
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Public title:
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Effect of Nasal Continuous Positive Airway Pressure (CPAP) on Oral Feeding in Human Neonates
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Scientific title:
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Effect of Nasal Continuous Positive Airway Pressure (CPAP) on Sucking, Swallowing and Coordination of Breathing and Swallowing During Oral Feeding in Human Neonates |
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Date of first enrolment:
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September 2010 |
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Target sample size:
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10 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01237015 |
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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: Single Group Assignment, Masking: Open Label
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Countries of recruitment
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Canada
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Contacts
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Name:
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Céline Catelin, MD |
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Address:
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Telephone:
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819 346 1110 |
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Email:
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celine.catelin@usherbrooke.ca |
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Affiliation:
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Name:
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Céline Catelin, MD |
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Address:
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Telephone:
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819 346 1110 |
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Email:
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celine.catelin@usherbrooke.ca |
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Affiliation:
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Name:
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Jean-Paul Praud, 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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Centre de recherche clinique Étienne Lebel |
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Name:
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Céline Catelin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Universitaire de Sherbrooke |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Gestational age 24 weeks or more
- Hospitalized in the neonatology unit or the maternity unit of CHUS Fleurimont
- Feeds by complete oral feeding since 24 hours or more
Exclusion Criteria:
- Upper airways anomaly
- Brain injury : periventricular leukomalacia or intracranial hemorrhage > grade III
(Papile classification)
- Neuromuscular disease
- Life-threatening congenital disease
- Any symptomatic intercurrent acute disease (ex.: infection)
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Oral Feeding in Human Neonates During Nasal CPAP
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Intervention(s)
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Device: Infant Flow nasal CPAP
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Primary Outcome(s)
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Continuous monitoring of sucking, swallowing, breathing and cardiac parameters
[Time Frame: 2 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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