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

This study is currently recruiting participants.
Verified May 2010 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01116765
First received: May 3, 2010
Last updated: May 4, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention
Preterm Infants
 Other: no stimulation of the oral structure
Other: stimulation of the oral structure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact of Early Oral Stimulation on Reducing Cardiorespiratory Events and Transition to Oral Feeding in Preterm Infants

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • the cardiorespiratory manifestations [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    to assess whether an oral stimulation program, before the introduction of oral feeding, enhances the cardiorespiratory manifestations


Secondary Outcome Measures:
  • the oral feeding performance [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    the oral feeding performance


Estimated Enrollment: 62
Study Start Date: March 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: experimental group
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
Infant in the control group receive no stimulation only non nutritive sucking during feeding
 Other: no stimulation of the oral structure

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

Ages Eligible for Study:   29 Weeks to 33 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116765

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France
Contact: MURIEL BUSUTIL         muriel.busutil@ap-hm.fr    
Principal Investigator: MURIEL BUSUTIL            
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: MURIEL BUSUTIL Assistance Publique Hopitaux De Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille, DIRECTION DE LA RECHERCHE
ClinicalTrials.gov Identifier: NCT01116765     History of Changes
Other Study ID Numbers: 2009-A01191-56, 2009-27
Study First Received: May 3, 2010
Last Updated: May 4, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique Hopitaux De Marseille:
preterm infants born between 26 to 29 weeks of gestation age.

ClinicalTrials.gov processed this record on June 18, 2013