- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01237015
Effect of Nasal Continuous Positive Airway Pressure (CPAP) on Oral Feeding in Human Neonates
Effect of Nasal Continuous Positive Airway Pressure (CPAP) on Sucking, Swallowing and Coordination of Breathing and Swallowing During Oral Feeding in Human Neonates
Current knowledge suggests that, to be successful, oral feeding in preterm babies should be initiated as soon as possible, often at an age where immature respiration still requires ventilatory support in the form of continuous positive airway pressure (CPAP). While some neonatologist teams claim great success with initiation of oral feeding in immature babies with CPAP, others strictly wait for CPAP to be no longer necessary before any attempt at oral feeding. Such controversy is fuelled by ignorance of the effects of CPAP on nutritive sucking and swallowing, including their coordination with breathing, and the fear to induce deleterious problems such as pulmonary aspiration of milk and/or respiratory failure. Ensuing delay in becoming proficient with oral feeding unduly prolongs hospital stays of preterm babies.
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Céline Catelin, MD
- Phone Number: 14169 819 346 1110
- Email: celine.catelin@usherbrooke.ca
Study Contact Backup
- Name: Jean-Paul Praud, MD-PhD
- Phone Number: 15363 819 346-1110
- Email: jean-paul.praud@usherbrooke.ca
Study Locations
-
-
Quebec
-
Sherbrooke, Quebec, Canada, J1H 5N4
- Recruiting
- Centre Hospitalier Universitaire de Sherbrooke - Fleurimont
-
Contact:
- Céline Catelin, MD
- Phone Number: 14169 819 346 1110
- Email: celine.catelin@usherbrooke.ca
-
Contact:
- Jean-Paul Praud, MD-PhD
- Phone Number: 15363 819 346 1110
- Email: jean-paul.praud@usherbrooke.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Continuous monitoring of sucking, swallowing, breathing and cardiac parameters
Time Frame: 2 days
|
2 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jean-Paul Praud, MD-PhD, Centre de recherche clinique Étienne Lebel
- Study Director: Céline Catelin, MD, Centre de recherche du Centre hospitalier Universitaire de Sherbrooke
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 07-157
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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