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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03651258
Other study ID # ALIJEU
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 19, 2017
Est. completion date July 30, 2018

Study information

Verified date January 2019
Source Centre Hospitalier Intercommunal Creteil
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The approach described here is based both on theoretical concepts and on the work of several teams of researchers. By positioning the baby and the appropriate adult, a speech bath, a sustained look and an expressive face, it is hypothesized that this early communication exercise will significantly improve the transition from passive feeding, active feeding of the premature child, from a qualitative and quantitative point of view.


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date July 30, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 4 Weeks
Eligibility Inclusion Criteria:

- Age of child at birth: <32 WA justified by the greater prevalence of oral disorders in these children.

- Age of the child at the start of the study: 35 WA, ie at the beginning of the establishment of active feeding within the unit.

Exclusion Criteria:

- Children with oral malformations

- Contra-indication to the realization to the ALIJEU (infection in progress, hemodynamic instability, etc.)

- Medical contraindications to oral diet

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Implementation of ALIJEU
The intervention concerns the passage from the passive feed (gastric tube) to the active feed (breast, feeding bottle). We propose to set up a pleasant moment just before his meal. This is a practical exercise of a few minutes. The aim of this special moment is to facilitate child-adult exchanges, improve active food intake and reduce the length of hospital stay.

Locations

Country Name City State
France CHI Créteil Créteil Ile De France

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary age at the stoppage of enteral nutrition 37 weeks of gestation
Secondary Duration of feeding Duration of the feeding in case of early game play 37 weeks of gestation
Secondary Quantities drunk Evaluate the quantities drunk in case of early game play 37 weeks of gestation
Secondary Awakening Duration of the the newborn's waking state at the time of suckling 37 weeks of gestation
Secondary Visual analogic scale for Satisfaction from 0 to 10 Assessing the satisfaction of the ALIJEU practice for the mother and the care team 37 weeks of gestation
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