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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01116765
Enrollment
53
Registered
2010-05-05
Start date
2010-05-01
Completion date
2023-04-13
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Infants

Keywords

preterm infants born between 26 to 29 weeks of gestation age.

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.

Interventions

OTHERno stimulation of the oral structure
OTHERstimulation of the oral structure

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
29 Weeks to 33 Weeks
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the cardiorespiratory manifestations2 yearsto assess whether an oral stimulation program, before the introduction of oral feeding, enhances the cardiorespiratory manifestations

Secondary

MeasureTime frameDescription
the oral feeding performance2 yearsthe oral feeding performance

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026