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

NCT ID: NCT04770844

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-23

Study Completion Date

2023-06-09

Brief Summary

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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.

Detailed Description

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Conditions

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Premature Birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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premature child

300 premature child will be included. They will have three acquisitions during hospitalization.

Acquisitions

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jean Monnet University

OTHER

Sponsor Role collaborator

Laboratoire EA SNA=EPIS 4607.

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ANTOINE GIRAUD, MD

Role: PRINCIPAL_INVESTIGATOR

CHU ST ETIENNE FRANCE

Locations

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Chu de St Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2020-A03335-34

Identifier Type: OTHER

Identifier Source: secondary_id

20CH234

Identifier Type: -

Identifier Source: org_study_id

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