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
  Purpose

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.


Condition Intervention
Oral Feeding in Human Neonates During Nasal CPAP
Device: Infant Flow nasal CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Effect of Nasal Continuous Positive Airway Pressure (CPAP) on Sucking, Swallowing and Coordination of Breathing and Swallowing During Oral Feeding in Human Neonates

Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Continuous monitoring of sucking, swallowing, breathing and cardiac parameters [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: September 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Infant Flow nasal CPAP
    Infant Flow nasal CPAP 5 cm H2O
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237015

Contacts
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

Locations
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke - Fleurimont Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
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   
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Study Director: Jean-Paul Praud, MD-PhD Centre de recherche clinique Étienne Lebel
Study Director: Céline Catelin, MD Centre Hospitalier Universitaire de Sherbrooke
  More Information

No publications provided

Responsible Party: Dre Céline Catelin, Centre Hospitalier Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT01237015     History of Changes
Other Study ID Numbers: 07-157
Study First Received: November 8, 2010
Last Updated: January 25, 2011
Health Authority: Canada: Health Canada

Keywords provided by Université de Sherbrooke:
Neonate
Oral feeding
Nasal CPAP
Sucking
Swallowing
Breathing

ClinicalTrials.gov processed this record on August 19, 2014