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

Terminated

• Conditions: Premature Birth
• Interventions: Other: Acquisitions

• Registration Number: NCT04770844
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-02-25
• Study Start: 2021-03-23
• Primary Completion: 2023-04-24
• Study Completion: 2023-06-09
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 129

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
premature child	Acquisitions	300 premature child will be included. They will have three acquisitions during hospitalization.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chu de St Etienne; 🇫🇷 Saint-Étienne, France