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

• Sponsor: Centre Hospitalier Intercommunal Creteil (Other)
• Overall Status: Completed
• CT.gov ID: NCT03651258
• Collaborator: (none)
• Enrollment: 59
• Location: 1
• Actual Duration (Months): 10.3
• Patients Per Site Per Month: 5.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immature Newborn; Feeding Behavior	Behavioral: Implementation of ALIJEU

Study Design

• Study Type: Observational
• Actual Enrollment: 59 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Facilitate the Transition From Passive Feeding to Active Feeding in Preterm Infants Through Early Play
• Actual Study Start Date: Sep 19, 2017
• Actual Primary Completion Date: May 1, 2018
• Actual Study Completion Date: Jul 30, 2018

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. age at the stoppage of enteral nutrition [37 weeks of gestation]

Secondary Outcome Measures

1. Duration of feeding [37 weeks of gestation]

   Duration of the feeding in case of early game play

2. Quantities drunk [37 weeks of gestation]

   Evaluate the quantities drunk in case of early game play

3. Awakening [37 weeks of gestation]

   Duration of the the newborn's waking state at the time of suckling

4. Visual analogic scale for Satisfaction from 0 to 10 [37 weeks of gestation]

   Assessing the satisfaction of the ALIJEU practice for the mother and the care team

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 4 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHI Créteil	Créteil	Ile De France	France	94000

Sponsors and Collaborators

• Centre Hospitalier Intercommunal Creteil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Intercommunal Creteil
• ClinicalTrials.gov Identifier: NCT03651258
• Other Study ID Numbers: ALIJEU
• First Posted: Aug 29, 2018
• Last Update Posted: Jan 15, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Intercommunal Creteil: Feeding Behavior

Study Results

No Results Posted as of Jan 15, 2019