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

Not Applicable

• Conditions: Oral Feeding in Human Neonates During Nasal CPAP

• Registration Number: NCT01237015
• Lead Sponsor: Université de Sherbrooke

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Status Verified: 2010-11
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-09
• Last Update Submitted: 2011-01-25
• Last Update Posted: 2011-01-26
• Primary Completion: 2012-09
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Continuous monitoring of sucking, swallowing, breathing and cardiac parameters	2 days

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Sherbrooke - Fleurimont; 🇨🇦 Sherbrooke, Quebec, Canada