Recruiting

CPAP

Sponsor:

Université de Sherbrooke

Code:

NCT01237015

Conditions

Oral Feeding in Human Neonates During Nasal CPAP

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Infant Flow nasal CPAP

Study Details

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.

Conditions

Oral Feeding in Human Neonates During Nasal CPAP

Study ID

NCT01237015

Start date

Sep, 2010

Status verified date

Nov, 2010

Completion date

Sep, 2012

Anticipated

Primary completion date

Sep, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Interventions and Outcome Measures

Interventions

Infant Flow nasal CPAP

Infant Flow nasal CPAP 5 cm H2O

Primary outcome measure

  • Continuous monitoring of sucking, swallowing, breathing and cardiac parameters [ Time Frame: 2 days ]

Central Contacts and Locations

Central contacts

Locations

Centre Hospitalier Universitaire de Sherbrooke - Fleurimont

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

More Information

Sponsor

Université de Sherbrooke

Last update posted

Jan 26, 2011

Last verified

Nov, 2010

Keywords

  • Neonate
  • Oral feeding
  • Nasal CPAP
  • Sucking
  • Swallowing
  • Breathing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2011-01-26.