Facilitate the Transition From Passive Feeding to Active Feeding in Preterm Infants Through Early Play (ALIJEU)

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.

Study Overview

• Status: Completed
• Conditions: Feeding Behavior; Immature Newborn
• Intervention / Treatment: Behavioral: Implementation of ALIJEU

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Créteil, Ile De France, France, 94000
      • CHI Créteil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Premate newborn with an age inferior to 32 weeks of amenorrhea at birth

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental group; patient who can benefit from the ALIJEU for certain meals	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.
Group of witnesses; patient who did not benefit from the ALIJEU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
age at the stoppage of enteral nutrition	37 weeks of gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of feeding	Duration of the feeding in case of early game play	37 weeks of gestation
Quantities drunk	Evaluate the quantities drunk in case of early game play	37 weeks of gestation
Awakening	Duration of the the newborn's waking state at the time of suckling	37 weeks of gestation
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2017
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 11, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Feeding Behavior
• Other Study ID Numbers: ALIJEU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No