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

NCT04770844 | Terminated

• 2 other identifiers: 20CH2342020-A03335-34
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

premature children; motor skill; developmental prognostic; prognostic tool

Outcome Measures

Primary Outcomes (3)

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

  Measured by analyze of all acquisitions.

  Year: 3

• Automatized quantification of variability of general movements (temporal variations)

  Measured by analyze of all acquisitions.

  Year: 3

• Automatized quantification of fluidity of general movements (uniform distribution)

  Measured by analyze of all acquisitions.

  Year: 3

Secondary Outcomes (1)

• Comparison between our quantitative analysis and qualitative analysis according to the reference method of Pretchl

  Year: 3

Study Arms (1)

premature child

300 premature child will be included. They will have three acquisitions during hospitalization.

Other: Acquisitions

Interventions

Acquisitions OTHER

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

premature child

Eligibility Criteria

• Age: 1 Day - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children borned before 33 week of amenorrhea

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Jean Monnet University: collaborator
• Laboratoire EA SNA=EPIS 4607.: collaborator

Study Sites (1)

Chu de St Etienne

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Health Facility Merger

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• ANTOINE GIRAUD, MD

  CHU ST ETIENNE FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: March 23, 2021
• Primary Completion: April 24, 2023
• Study Completion: June 9, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)