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

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ClinicalTrials.gov Identifier: NCT01116765
Recruitment Status : Unknown
Verified April 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Active, not recruiting
First Posted : May 5, 2010
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Preterm Infants Other: no stimulation of the oral structure Other: 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Early Oral Stimulation on Reducing Cardiorespiratory Events and Transition to Oral Feeding in Preterm Infants
Study Start Date : May 2010
Primary Completion Date : March 2014
Estimated Study Completion Date : April 2016
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. the cardiorespiratory manifestations [ Time Frame: 2 years ]
    to assess whether an oral stimulation program, before the introduction of oral feeding, enhances the cardiorespiratory manifestations


Secondary Outcome Measures :
  1. the oral feeding performance [ Time Frame: 2 years ]
    the oral feeding performance


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   29 Weeks to 33 Weeks   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01116765


Locations
France
Assistance Publique Hopitaux de Marseille
Marseille, France
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: MURIEL BUSUTIL Assistance Publique Hopitaux De Marseille
More Information

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01116765     History of Changes
Other Study ID Numbers: 2009-A01191-56
2009-27 ( Other Identifier: 2009-27 )
First Posted: May 5, 2010    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications