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

NCT01116765 | Completed

• 2 other identifiers: 2009-A01191-562009-27
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infants

Keywords

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

Outcome Measures

Primary Outcomes (1)

• the cardiorespiratory manifestations

  to assess whether an oral stimulation program, before the introduction of oral feeding, enhances the cardiorespiratory manifestations

  2 years

Secondary Outcomes (1)

• the oral feeding performance

  2 years

Study Arms (2)

experimental group

EXPERIMENTAL

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

Other: stimulation of the oral structure

control group

OTHER

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

Other: no stimulation of the oral structure

Interventions

no stimulation of the oral structure OTHER

control group

stimulation of the oral structure OTHER

experimental group

Eligibility Criteria

• Age: 29 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, France

Location

Study Officials

• MURIEL BUSUTIL

  Assistance Publique Hopitaux De Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 5, 2010
• Study Start: May 1, 2010
• Primary Completion: February 24, 2014
• Study Completion: April 13, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

FR (1)