Back to resultsImpact of Early Oral Stimulation on Reducing Cardiorespiratory Events and Transition to Oral Feeding in Preterm Infants
Primary Purpose
Preterm Infants
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
no stimulation of the oral structure
stimulation of the oral structure
Sponsored by
About this trial
This is an interventional prevention trial for Preterm Infants focused on measuring preterm infants born between 26 to 29 weeks of gestation age.
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.
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
experimental group
control group
Arm Description
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
Outcomes
Primary Outcome Measures
the cardiorespiratory manifestations
to assess whether an oral stimulation program, before the introduction of oral feeding, enhances the cardiorespiratory manifestations
Secondary Outcome Measures
the oral feeding performance
the oral feeding performance
Full Information
NCT ID
NCT01116765
First Posted
May 3, 2010
Last Updated
April 13, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT01116765
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2010 (Actual)
Primary Completion Date
February 24, 2014 (Actual)
Study Completion Date
April 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants
Keywords
preterm infants born between 26 to 29 weeks of gestation age.
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
Infants in the experimental group receive an oral stimulation program consisting of stimulation of the oral structures during 10 consecutive days
Arm Title
control group
Arm Type
Other
Arm Description
Infant in the control group receive no stimulation only non nutritive sucking during feeding
Intervention Type
Other
Intervention Name(s)
no stimulation of the oral structure
Intervention Type
Other
Intervention Name(s)
stimulation of the oral structure
Primary Outcome Measure Information:
Title
the cardiorespiratory manifestations
Description
to assess whether an oral stimulation program, before the introduction of oral feeding, enhances the cardiorespiratory manifestations
Time Frame
2 years
Secondary Outcome Measure Information:
Title
the oral feeding performance
Description
the oral feeding performance
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Weeks
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MURIEL BUSUTIL
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
Country
France
12. IPD Sharing Statement
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Impact of Early Oral Stimulation on Reducing Cardiorespiratory Events and Transition to Oral Feeding in Preterm Infants
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