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Clinical Trials/NCT04770844
NCT04770844
Terminated
N/A

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

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country129 target enrollmentMarch 23, 2021
ConditionsPremature Birth

Overview

Phase
N/A
Intervention
Not specified
Conditions
Premature Birth
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
129
Locations
1
Primary Endpoint
Automatized quantification of complexity of general movements (spatial variation).
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 23, 2021
End Date
June 9, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Automatized quantification of complexity of general movements (spatial variation).

Time Frame: Year: 3

Measured by analyze of all acquisitions.

Automatized quantification of variability of general movements (temporal variations)

Time Frame: Year: 3

Measured by analyze of all acquisitions.

Automatized quantification of fluidity of general movements (uniform distribution)

Time Frame: Year: 3

Measured by analyze of all acquisitions.

Secondary Outcomes

  • Comparison between our quantitative analysis and qualitative analysis according to the reference method of Pretchl(Year: 3)

Study Sites (1)

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