Trials / Completed
CompletedNCT01116765
Impact of Early Oral Stimulation on Reducing Cardiorespiratory Events and Transition to Oral Feeding in Preterm Infants
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 53 (actual)
- Sponsor
- Assistance Publique Hopitaux De Marseille · Academic / Other
- Sex
- All
- Age
- 29 Weeks – 33 Weeks
- Healthy volunteers
- Not accepted
Summary
To assess whether an oral stimulation program, before the introduction of oral feeding, enhances the cardiorespiratory manifestations (episodes of oxygen désaturations, and/or apnea- bradycardia), and the oral feeding performance, in preterm infants born between 26 to 29 weeks of gestation age.
Detailed description
Preterm infant were randomized into an experimental or an control group. Infants in the experimental group receive an oral stimulation program consisting of stimulation of the oral structures during 10 consecutive days. Infant in the control group receive no stimulation only non nutritive sucking during feeding. Both were administered twice per day, during 20 minutes, 48 hours after discontinuation of nasal continuous positive air pressure. A long term evaluation of oral feeding difficulties and neuromotor development are organized.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | no stimulation of the oral structure | |
| OTHER | stimulation of the oral structure |
Timeline
- Start date
- 2010-05-01
- Primary completion
- 2014-02-24
- Completion
- 2023-04-13
- First posted
- 2010-05-05
- Last updated
- 2023-04-18
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT01116765. Inclusion in this directory is not an endorsement.