Effect of Nasal Continuous Positive Airway Pressure (CPAP) on Oral Feeding in Human Neonates
NCT ID: NCT01237015
Last Updated: 2011-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2010-09-30
2012-09-30
Brief Summary
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The aim of this study is to evaluate the effects of nasal CPAP on oral feeding in human neonates. More specifically, CPAP effects on nutritive sucking and swallowing, including on breathing-swallowing coordination, will be carefully assessed. The investigators hypothesize that nasal CPAP will lead to no or minimal alterations of breathing-nutritive swallowing coordination and will not induce deleterious cardiorespiratory events.
Accordingly, each neonate will be evaluated during 2 bottle feedings spaced of 24 h, one with nasal CPAP 5 cm H2O and the other without any CPAP. Sucking and swallowing activity, respiration, heart rate and oxygenation will be continuously recorded before, during and after bottle-feeding.
By filling a gap in knowledge, results from the study will hopefully help neonatologists afraid of doing more harm than good when initiating bottle-feeding in preterm babies under CPAP to join the many teams for whom it is no more a problem.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
NONE
Interventions
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Infant Flow nasal CPAP
Infant Flow nasal CPAP 5 cm H2O
Eligibility Criteria
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Inclusion Criteria
* Hospitalized in the neonatology unit or the maternity unit of CHUS Fleurimont
* Feeds by complete oral feeding since 24 hours or more
Exclusion Criteria
* Brain injury : periventricular leukomalacia or intracranial hemorrhage \> grade III (Papile classification)
* Neuromuscular disease
* Life-threatening congenital disease
* Any symptomatic intercurrent acute disease (ex.: infection)
ALL
Yes
Sponsors
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Université de Sherbrooke
OTHER
Responsible Party
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Centre Hospitalier Universitaire de Sherbrooke
Principal Investigators
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Jean-Paul Praud, MD-PhD
Role: STUDY_DIRECTOR
Centre de recherche clinique Étienne Lebel
Céline Catelin, MD
Role: STUDY_DIRECTOR
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Locations
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Centre Hospitalier Universitaire de Sherbrooke - Fleurimont
Sherbrooke, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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07-157
Identifier Type: -
Identifier Source: org_study_id
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