Impact of Early Oral Stimulation on Reducing Cardiorespiratory Events and Transition to Oral Feeding in Preterm Infants
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: experimental group Infants in the experimental group receive an oral stimulation program consisting of stimulation of the oral structures during 10 consecutive days |
Other: stimulation of the oral structure
|
| Other: control group Infant in the control group receive no stimulation only non nutritive sucking during feeding |
Other: no stimulation of the oral structure
|
Outcome Measures
Primary Outcome Measures
- the cardiorespiratory manifestations [2 years]
to assess whether an oral stimulation program, before the introduction of oral feeding, enhances the cardiorespiratory manifestations
Secondary Outcome Measures
- the oral feeding performance [2 years]
the oral feeding performance
Eligibility Criteria
Criteria
Inclusion Criteria:
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Children whose born term is included between 26 and 29SA past and whose postnatal age is lower or more equal in 33SA past, at the time of the inclusion.
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Term of certain child (calculated according to the date of the last rules and\or a premature obstetric echography).
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Children devoid of neurological pathology making him(it) clinically unstable (echography transfontanellar and\or intellectual MRI, electroencephalogram normal, either, intraventricular bleeding of rank 1 and 2 of Papile [40], or, intellectual abnormalities in the MRI of type(chap) 1 - 4 according to the classification of modified Paneth [41]. (Annex X)
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Children devoid of infectious pathology making him(it) clinically unstable (Protein C-reactive lower than 7).
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In case of ebb gastroenteritis - esophageal symptomatic ( RGO): the child will be treated(handled), by oral route, by location + thickening +/-prokinetic +/-inhibitor pumps in proton.
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According to a protocol of service, all the premature babies of less than 32.
Exclusion Criteria:
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Born Child > 29 limited companies.
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Child not included at the postnatal age of 33 past(over) LIMITED COMPANIES.
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Child presenting a genic syndrome, an evolutionary neurological disease, a pathology malformative.
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Child presenting a bleeding intraventricular of rank 3-4 [ 40 ], intellectual abnormalities in the MRI of type(chap) 5 and 6 according to the classification of modified Paneth [ 41 ], an ulcer-necrotizing entérocolitis.
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Child among whom both relatives(parents) or legal representatives refused that their child participates in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Assistance Publique Hopitaux de Marseille | Marseille | France |
Sponsors and Collaborators
- Assistance Publique Hopitaux De Marseille
Investigators
- Principal Investigator: MURIEL BUSUTIL, Assistance Publique Hopitaux De Marseille
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2009-A01191-56
- 2009-27