NCT03322722

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 16, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2022

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

3.2 years

First QC Date

October 16, 2017

Last Update Submit

April 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Age of prematurity of the newborn child

    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

Eligibility Criteria

Age1 Day - 5 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

  • SUILS Hélène, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 26, 2017

Study Start

October 14, 2016

Primary Completion

December 31, 2019

Study Completion

December 7, 2022

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations