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

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Terminated

Conditions

Premature Birth

Treatments

Other: Acquisitions

Study type

Observational

Funder types

Other

Identifiers

NCT04770844
20CH234
2020-A03335-34 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

129 patients

Sex

All

Ages

1 day to 3 months old

Volunteers

No Healthy Volunteers

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.

Trial design

129 participants in 1 patient group

premature child
Description:
300 premature child will be included. They will have three acquisitions during hospitalization.
Treatment:
Other: Acquisitions

Trial contacts and locations

1

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Central trial contact

ANTOINE GIRAUD, MD; Fleur PETIT, CRA

Data sourced from clinicaltrials.gov

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