Development of a Developmental Prognostic Tool for the Premature Child Based on Automated Spontaneous Motor Analysis (AGMA)

January 2, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne
Prematurity is a major risk factor for poor neurodevelopmental outcomes. The clinical and neuroradiological evaluations proposed during the neonatal period to assess the developmental prognosis of children born prematurely are not sensitive and nor specific. The analysis of spontaneous motor activity by Prechtl's method has a better predictive value but is currently unfeasible in clinical routine. The study's principal objective is to describe the standardized values of complexity, variability, and fluidity of general movements.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

129

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • France
      • Saint-Étienne, France, 42000
        • CHU de St Etienne

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 3 months (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

children borned before 33 week of amenorrhea

Description

Inclusion Criteria:

  • Birth before 33 week of amenorrhea;
  • Hospitalization in the Neonatal Department of the Saint-Étienne University Hospital
  • Patient affiliated or entitled to a social security scheme;
  • Authorization to shoot the holders of parental authority;
  • Consent to participate in the study by the holders of parental authority

Exclusion Criteria:

  • Need for ventilatory support;
  • Difficulty of thermal regulation contraindicating the use of a heating cradle;
  • Refusal of authorization to shoot by holders of parental authority;
  • Refusal of participation in the study of holders of parental authority.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
premature child
300 premature child will be included. They will have three acquisitions during hospitalization.
Other: Acquisitions

Three acquisitions of 1 hours during hospitalization will be realized:

  • a few days after hospitalization,
  • in the middle of the hospitalization,
  • a few days before hospital discharge. The child will be lying on his back in a heated cradle and filmed with a specific camera. The signal will be obtained by 2k ZED 2 stereo camera in order to obtain a three-dimensional location of the child

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Automatized quantification of complexity of general movements (spatial variation).
Time Frame: Year: 3
Measured by analyze of all acquisitions.
Year: 3
Automatized quantification of variability of general movements (temporal variations)
Time Frame: Year: 3
Measured by analyze of all acquisitions.
Year: 3
Automatized quantification of fluidity of general movements (uniform distribution)
Time Frame: Year: 3
Measured by analyze of all acquisitions.
Year: 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between our quantitative analysis and qualitative analysis according to the reference method of Pretchl
Time Frame: Year: 3
Measured by analyze of all acquisitions.
Year: 3

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Université Jean Monnet, Saint-Étienne, France.
Laboratoire EA SNA=EPIS 4607.

Investigators

  • Principal Investigator: ANTOINE GIRAUD, MD, CHU ST ETIENNE FRANCE

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)

March 23, 2021

Primary Completion (Actual)

April 24, 2023

Study Completion (Actual)

June 9, 2023

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

February 24, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20CH234
  • 2020-A03335-34 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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 Premature Birth

Clinical Trials on Acquisitions

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe