Feeding Behavior Clinical Trial
— ALIJEUOfficial title:
Facilitate the Transition From Passive Feeding to Active Feeding in Preterm Infants Through Early Play
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 |
Verified date | January 2019 |
Source | Centre Hospitalier Intercommunal Creteil |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHI Créteil | Créteil | Ile De France |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Intercommunal Creteil |
France,
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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