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

NCT ID: NCT01237015

Last Updated: 2011-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-09-30

Brief Summary

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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

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Conditions

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Oral Feeding in Human Neonates During Nasal CPAP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Infant Flow nasal CPAP

Infant Flow nasal CPAP 5 cm H2O

Intervention Type DEVICE

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Centre Hospitalier Universitaire de Sherbrooke

Principal Investigators

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Jean-Paul Praud, MD-PhD

Role: STUDY_DIRECTOR

Centre de recherche clinique Étienne Lebel

Céline Catelin, MD

Role: STUDY_DIRECTOR

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Locations

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Centre Hospitalier Universitaire de Sherbrooke - Fleurimont

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Céline Catelin, MD

Role: CONTACT

819 346 1110 ext. 14169

Jean-Paul Praud, MD-PhD

Role: CONTACT

819 346-1110 ext. 15363

Facility Contacts

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Céline Catelin, MD

Role: primary

819 346 1110 ext. 14169

Jean-Paul Praud, MD-PhD

Role: backup

819 346 1110 ext. 15363

Other Identifiers

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07-157

Identifier Type: -

Identifier Source: org_study_id

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