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

Preterm Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116765
• Other study ID #: 2009-A01191-56
• Secondary ID: 2009-27
• Status: Completed
• Phase: N/A
• Start date: May 1, 2010
• Est. completion date: April 13, 2023

Study information

• Verified date: April 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 13, 2023
• Est. primary completion date: February 24, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Weeks to 33 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infants

Intervention

Other:
• no stimulation of the oral structure

• stimulation of the oral structure

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the cardiorespiratory manifestations	to assess whether an oral stimulation program, before the introduction of oral feeding, enhances the cardiorespiratory manifestations	2 years
Secondary	the oral feeding performance	the oral feeding performance	2 years