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Impact of Early Oral Stimulation on Reducing Cardiorespiratory Events and Transition to Oral Feeding in Preterm Infants | Clinical Trials | Clareo Health

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

NCT01116765•Assistance Publique Hopitaux De Marseille

View on ClinicalTrials.gov

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

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Assistance Publique Hopitaux de Marseille

Marseille, France

Key Dates

Start Date

May 1, 2010

Primary Completion Date

February 24, 2014

Completion Date

April 13, 2023

Last Updated

April 18, 2023

Enrollment

ACTUAL participants

Conditions

Preterm Infants

Interventions

no stimulation of the oral structure

OTHER

stimulation of the oral structure

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)

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