Implementation of a Tool on Alimentary Empowerment in New-born Baby

April 26, 2023 updated by: Groupe Hospitalier Paris Saint Joseph
The alimentation of the premature newborn children is one of main thing concerning of nurses and pediatricians in neonatology. The absence of common tool of evaluation of the children cause a great discrepancy in prescriptions and the practices of the nursing.The aim of this study is to estimate the improvement of the food empowerment of the premature newborn children after the introduction of a help tool at the food progress which allows to fit the prescription of food(supply) to the capacities of the newborn child.

Study Overview

Status

Completed

Detailed Description

If the importance of feeding premature newborns is a central concern during their management, the absence of an evaluation tool leads to a great disparity in their implementation (particularly marked by at regular times by the care teams), which can eventually lead to oral disorders. The possibility of an assessment of the newborn's skills could allow a homogenization of therapeutic proposals and thus a potentially faster progression of dietary independence of the newborn. This method could also encourage parental involvement in feeding care. The objective of the study is to evaluate the impact of a tool to help food progression on food autonomy.

Study Type

Observational

Enrollment (Actual)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Groupe hospitalier Paris saint Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 5 days (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

every baby born before 37 weeks of pregnancy between january 2017 and end of march 2017

Description

Inclusion Criteria:

  • born before 37 weeks of pregnancy
  • hospitalized in GHPSJ neonatology
  • Predictable duration of hospitalization of at least 7 days

Exclusion Criteria:

  • parents not speaking french language
  • new borm with complication du to his prematurity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age of prematurity of the newborn child
Time Frame: delivery date
It's an estimation between the real age of the premature baby (i.e number of weeks of pregnancy) and the normal date of delivery.
delivery date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: SUILS Hélène, MD, Groupe hospitalier Paris saint Joseph

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2016

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 7, 2022

Study Registration Dates

First Submitted

October 16, 2017

First Submitted That Met QC Criteria

October 23, 2017

First Posted (Actual)

October 26, 2017

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAVOILACTEE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neonatal Feeding Disorder

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