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Completed

NCT Number: NCT03651258

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

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.

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Key information

Conditions

Immature Newborn Behavior Behavior, Animal Feeding Behavior

Age range

Up to 4 week

Sex eligibility

All sexes

Study type

Observational

Primary location

CHI Créteil

Créteil, Île-de-France Region, 94000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implementation of ALIJEU

Behavioral

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.

Primary outcomes

  1. age at the stoppage of enteral nutrition

    Time frame: 37 weeks of gestation

Secondary outcomes

  1. Duration of feeding

    Time frame: 37 weeks of gestation

    Duration of the feeding in case of early game play

  2. Quantities drunk

    Time frame: 37 weeks of gestation

    Evaluate the quantities drunk in case of early game play

  3. Awakening

    Time frame: 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

    Time frame: 37 weeks of gestation

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Acronym: ALIJEU

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 29, 2018
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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