Premature BirthAGMANCT04770844
Development of a Developmental Prognostic Tool for the Premature Child Based on Automated Spontaneous Motor Analysis
An observational study of Premature Birth, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 day to 3 months
- Conditions the study is for
- Premature Birth
- What is being tested?
- Acquisitions
- How many people
- 129 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2021to 9 Jun 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: children borned before 33 week of amenorrhea
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Acquisitions
- Keywords
- premature children, motor skill, developmental prognostic, prognostic tool
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcquisitionsOther
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 group | Role | What they receive |
|---|---|---|
| premature child | 300 premature child will be included. They will have three acquisitions during hospitalization. Receives: Other: Acquisitions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Automatized quantification of complexity of general movements (spatial variation).
Measured by analyze of all acquisitions.
Measured: Year: 3
Automatized quantification of variability of general movements (temporal variations)
Measured by analyze of all acquisitions.
Measured: Year: 3
Automatized quantification of fluidity of general movements (uniform distribution)
Measured by analyze of all acquisitions.
Measured: Year: 3
Secondary outcomes (1)
Comparison between our quantitative analysis and qualitative analysis according to the reference method of Pretchl
Measured by analyze of all acquisitions.
Measured: Year: 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start23 Mar 2021
- Primary completion24 Apr 2023
- Study completion9 Jun 2023
Why it stopped: inclusion difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jean Monnet University, Laboratoire EA SNA=EPIS 4607.
- Responsible party
- Sponsor
- Investigators
- ANTOINE GIRAUD, MD, Principal investigator, CHU ST ETIENNE FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770844
- Sponsor's protocol ID
- 20CH234
- Other IDs
- 2020-A03335-34
- Acronym
- AGMA
- Status last verified
- Jan 2024
- First submitted
- 22 Feb 2021
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Developmental Prognostic Tool for the Premature Child Based on Automated Spontaneous Motor Analysis
- ClinicalTrials.gov ID
- NCT04770844
- Acronym / sponsor ID
- AGMA / 20CH234
- Conditions
- Premature Birth
- Keywords
- premature children, motor skill, developmental prognostic, prognostic tool
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: inclusion difficulties
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Jean Monnet University, Laboratoire EA SNA=EPIS 4607.
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 9 Jun 2023 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| premature child | – | Other: Acquisitions300 premature child will be included. They will have three acquisitions during hospitalization. |
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children borned before 33 week of amenorrhea
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcquisitionsThree 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 | Other | premature child |
Primary outcome
Automatized quantification of complexity of general movements (spatial variation).
Time frame: Year: 3
Measured by analyze of all acquisitions.
Automatized quantification of variability of general movements (temporal variations)
Time frame: Year: 3
Measured by analyze of all acquisitions.
Automatized quantification of fluidity of general movements (uniform distribution)
Time frame: Year: 3
Measured by analyze of all acquisitions.
1 secondary outcome
Comparison between our quantitative analysis and qualitative analysis according to the reference method of Pretchl
Time frame: Year: 3
Results and safety
The study was stopped early (reason given: inclusion difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANTOINE GIRAUD, MD principal investigator
CHU ST ETIENNE FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: inclusion difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Automatized quantification of complexity of general movements (spatial variation). (time frame: Year: 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.