Impact of Early Oral Stimulation on Reducing Cardiorespiratory Events and Transition to Oral Feeding in Preterm Infants

NCT ID: NCT01116765

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-01
• Study Completion Date: 2023-04-13

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.

Conditions

Preterm Infants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

experimental group

Infants in the experimental group receive an oral stimulation program consisting of stimulation of the oral structures during 10 consecutive days

Group Type: EXPERIMENTAL

stimulation of the oral structure

Intervention Type: OTHER

control group

Infant in the control group receive no stimulation only non nutritive sucking during feeding

Group Type: OTHER

no stimulation of the oral structure

Intervention Type: OTHER

Interventions

no stimulation of the oral structure

Intervention Type: OTHER

stimulation of the oral structure

Intervention Type: OTHER

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.

• Minimum Eligible Age: 29 Weeks
• Maximum Eligible Age: 33 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MURIEL BUSUTIL

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hopitaux De Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2009-27

Identifier Type: OTHER

Identifier Source: secondary_id

2009-A01191-56

Identifier Type: -

Identifier Source: org_study_id