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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04770844

Acronym

AGMA

Enrollment

129

Registered

2021-02-25

Start date

2021-03-23

Completion date

2023-06-09

Last updated

2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

Keywords

premature children, motor skill, developmental prognostic, prognostic tool

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.

Interventions

OTHERAcquisitions

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 3 Months

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026