- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03322722
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
Conditions
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
-
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Ile-de-France
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Paris, Ile-de-France, France, 75014
- Groupe hospitalier Paris saint Joseph
-
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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.
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