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

Premature Birth Clinical Trial

— AGMA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04770844
• Other study ID #: 20CH234
• Secondary ID: 2020-A03335-34
• Status: Terminated
• Start date: March 23, 2021
• Est. completion date: June 9, 2023

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 129
• Est. completion date: June 9, 2023
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 3 Months

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth

Intervention

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

Locations

Country	Name	City	State
France	Chu de St Etienne	Saint-Étienne

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Laboratoire EA SNA=EPIS 4607., Université Jean Monnet, Saint-Étienne, France.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Automatized quantification of complexity of general movements (spatial variation).	Measured by analyze of all acquisitions.	Year: 3
Primary	Automatized quantification of variability of general movements (temporal variations)	Measured by analyze of all acquisitions.	Year: 3
Primary	Automatized quantification of fluidity of general movements (uniform distribution)	Measured by analyze of all acquisitions.	Year: 3
Secondary	Comparison between our quantitative analysis and qualitative analysis according to the reference method of Pretchl	Measured by analyze of all acquisitions.	Year: 3