NCT03651258

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2018

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

April 4, 2018

Last Update Submit

January 11, 2019

Conditions

Keywords

Feeding Behavior

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

Behavioral: Implementation of ALIJEU

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.

Experimental group

Eligibility Criteria

AgeUp to 4 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

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

Locations