Overview

This trial is active, not recruiting.

Condition preterm infants
Treatments no stimulation of the oral structure, stimulation of the oral structure
Sponsor Assistance Publique Hopitaux De Marseille
Start date May 2010
End date March 2014
Trial size 62 participants
Trial identifier NCT01116765, 2009-27, 2009-A01191-56

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Infants in the experimental group receive an oral stimulation program consisting of stimulation of the oral structures during 10 consecutive days
stimulation of the oral structure
(Other)
Infant in the control group receive no stimulation only non nutritive sucking during feeding
no stimulation of the oral structure

Primary Outcomes

Measure
the cardiorespiratory manifestations
time frame: 2 years

Secondary Outcomes

Measure
the oral feeding performance
time frame: 2 years

Eligibility Criteria

Male or female participants from 29 weeks up to 33 weeks old.

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.

Additional Information

Official title Impact of Early Oral Stimulation on Reducing Cardiorespiratory Events and Transition to Oral Feeding in Preterm Infants
Principal investigator MURIEL BUSUTIL
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille.