Effect of Nasal Continuous Positive Airway Pressure (CPAP) on Oral Feeding in Human Neonates

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Université de Sherbrooke.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01237015
First received: November 8, 2010
Last updated: January 25, 2011
Last verified: November 2010

November 8, 2010
January 25, 2011
September 2010
September 2012   (final data collection date for primary outcome measure)
Continuous monitoring of sucking, swallowing, breathing and cardiac parameters [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01237015 on ClinicalTrials.gov Archive Site
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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.

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Interventional
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Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Oral Feeding in Human Neonates During Nasal CPAP
Device: Infant Flow nasal CPAP
Infant Flow nasal CPAP 5 cm H2O
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
September 2012
September 2012   (final data collection date for primary outcome measure)

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)
Both
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Yes
Contact: Céline Catelin, MD 819 346 1110 ext 14169 celine.catelin@usherbrooke.ca
Contact: Jean-Paul Praud, MD-PhD 819 346-1110 ext 15363 jean-paul.praud@usherbrooke.ca
Canada
 
NCT01237015
07-157
Yes
Dre Céline Catelin, Centre Hospitalier Universitaire de Sherbrooke
Université de Sherbrooke
Not Provided
Study Director: Jean-Paul Praud, MD-PhD Centre de recherche clinique Étienne Lebel
Study Director: Céline Catelin, MD Centre Hospitalier Universitaire de Sherbrooke
Université de Sherbrooke
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP