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OpenTrials
Completed

NCT Number: NCT01116765

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

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.

Completed

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Key information

Conditions

Age range

29 week–33 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

no stimulation of the oral structure

Other

stimulation of the oral structure

Other

Primary outcomes

  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 outcomes

  1. the oral feeding performance

    Time frame: 2 years

    the oral feeding performance

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2023
First posted
May 5, 2010
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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