Facilitate the Transition From Passive Feeding to Active Feeding in Preterm Infants Through Early Play
ALIJEU
1 other identifier
observational
59
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 19, 2017
CompletedFirst Submitted
Initial submission to the registry
April 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2018
CompletedFirst Posted
Study publicly available on registry
August 29, 2018
CompletedJanuary 15, 2019
January 1, 2019
7 months
April 4, 2018
January 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
age at the stoppage of enteral nutrition
37 weeks of gestation
Secondary Outcomes (4)
Duration of feeding
37 weeks of gestation
Quantities drunk
37 weeks of gestation
Awakening
37 weeks of gestation
Visual analogic scale for Satisfaction from 0 to 10
37 weeks of gestation
Study Arms (2)
Experimental group
patient who can benefit from the ALIJEU for certain meals
Group of witnesses
patient who did not benefit from the ALIJEU
Interventions
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.
Eligibility Criteria
Premate newborn with an age inferior to 32 weeks of amenorrhea at birth
You may qualify if:
- 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.
You may not qualify if:
- Children with oral malformations
- Contra-indication to the realization to the ALIJEU (infection in progress, hemodynamic instability, etc.)
- Medical contraindications to oral diet
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHI Créteil
Créteil, Île-de-France Region, 94000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2018
First Posted
August 29, 2018
Study Start
September 19, 2017
Primary Completion
May 1, 2018
Study Completion
July 30, 2018
Last Updated
January 15, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share