Clinical trial NCT01116765: Impact of Early Oral Stimulation on Reducing Cardiorespiratory Events and Transition to Oral Feeding in Preterm Infants
Official title: Impact of Early Oral Stimulation on Reducing Cardiorespiratory Events and Transition to Oral Feeding in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infants
Keywords: preterm infants born between 26 to 29 weeks of gestation age.
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 53
Sex: ALL
Minimum age (years): 29
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.
* Term of certain child (calculated according to the date of the last rules and\\or a premature obstetric echography).
* 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)
* Children devoid of infectious pathology making him(it) clinically unstable (Protein C-reactive lower than 7).
* 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.
* According to a protocol of service, all the premature babies of less than 32.

Exclusion Criteria:

* Born Child \> 29 limited companies.
* Child not included at the postnatal age of 33 past(over) LIMITED COMPANIES.
* Child presenting a genic syndrome, an evolutionary neurological disease, a pathology malformative.
* 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.
* Child among whom both relatives(parents) or legal representatives refused that their child participates in the study.

Primary outcomes:
measure: the cardiorespiratory manifestations
timeFrame: 2 years
Secondary outcomes:
measure: the oral feeding performance
timeFrame: 2 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: MURIEL BUSUTIL
role: PRINCIPAL_INVESTIGATOR
References: