Effect of Nasal Continuous Positive Airway Pressure (CPAP) on Oral Feeding in Human Neonates
|ClinicalTrials.gov Identifier: NCT01237015|
Recruitment Status : Unknown
Verified November 2010 by Université de Sherbrooke.
Recruitment status was: Recruiting
First Posted : November 9, 2010
Last Update Posted : January 26, 2011
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 or disease||Intervention/treatment||Phase|
|Oral Feeding in Human Neonates During Nasal CPAP||Device: Infant Flow nasal CPAP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||September 2012|
Device: Infant Flow nasal CPAP
- Continuous monitoring of sucking, swallowing, breathing and cardiac parameters [ Time Frame: 2 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237015
|Contact: Céline Catelin, MD||819 346 1110 ext email@example.com|
|Contact: Jean-Paul Praud, MD-PhD||819 346-1110 ext firstname.lastname@example.org|
|Centre Hospitalier Universitaire de Sherbrooke - Fleurimont||Recruiting|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Contact: Céline Catelin, MD 819 346 1110 ext 14169 email@example.com|
|Contact: Jean-Paul Praud, MD-PhD 819 346 1110 ext 15363 firstname.lastname@example.org|
|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|