SleepDODOPREMANCT03432182
Body Movements Analysis During Sleep in Very Premature Infants
A study testing electroencephalography in people with Sleep, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Sleep is a key factor for normal brain development of the newborn. However, it is poorly studied and little is known about its characterization, especially in premature infants. Body movements during sleep are easy to evaluate but studies on their relationship to normal sleep states are scarce and limited. Read more about this study
- Who is it for?
- Ages 10 to 15 days
- Conditions the study is for
- Sleep
- What is being tested?
- electroencephalography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2018to 15 Aug 2024
- Phase
- Interventional
- 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 10 to 15 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born between 26 and 32 weeks gestation
Who cannot join
- Genetic abnormality
- Neurological pathology such as intraventricular hemorrhage > grade 2
- Any medication know for altering electroencephalography recording
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Movements Occurring During Sleep in Very Premature Neonates: Relationship With Neurodevelopmental Outcome
Sleep is a key factor for normal brain development of the newborn. However, it is poorly studied and little is known about its characterization, especially in premature infants. Body movements during sleep are easy to evaluate but studies on their relationship to normal sleep states are scarce and limited. This project aims to characterize body movements during sleep, assessed by electroencephalography, in very premature infants. Then, a correlation between body movements, sleep organization and neurodevelopmental outcome will be evaluated at 3 years of age.
- Conditions
- Sleep
- Being tested
- electroencephalography
- Keywords
- Premature infant, sleep state, body movement, neurodevelopmental outcome
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroencephalographyDiagnostic test
Sleep states definition by electroencephalograpy
| Study group | Role | What they receive |
|---|---|---|
| very premature infants | Other | Electroencephalography allowing sleep observation Receives: Diagnostic Test: electroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body movements evaluation during sleep
number of movements observed according to sleep states
Measured: 3 months
Secondary outcomes (3)
Sleep states organization
sleep states characterization by electroencephalography according to postmenstrual age
Measured: 3 months
Type of movements observed during sleep
Movements characterization according to sleep states
Measured: 3 months
Neurodevelopmental outcome
neuropsychomotor evaluation by Bayley psychometric test
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start28 Feb 2018
- Primary completion30 Jun 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Michel HASCOET, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432182
- Sponsor's protocol ID
- 2017-A02687-46
- Acronym
- DODOPREMA
- Status last verified
- Aug 2024
- First submitted
- 1 Feb 2018
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Movements Occurring During Sleep in Very Premature Neonates: Relationship With Neurodevelopmental Outcome
- ClinicalTrials.gov ID
- NCT03432182
- Acronym / sponsor ID
- DODOPREMA / 2017-A02687-46
- Conditions
- Sleep
- Keywords
- Premature infant, sleep state, body movement, neurodevelopmental outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 14 Feb 2018 (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.
Sleep is a key factor for normal brain development of the newborn. However, it is poorly studied and little is known about its characterization, especially in premature infants. Body movements during sleep are easy to evaluate but studies on their relationship to normal sleep states are scarce and limited. This project aims to characterize body movements during sleep, assessed by electroencephalography, in very premature infants. Then, a correlation between body movements, sleep organization and neurodevelopmental outcome will be evaluated at 3 years of age.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| very premature infants | Other | Diagnostic Test: electroencephalographyElectroencephalography allowing sleep observation |
Who may qualify
- Ages
- 10 to 15 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants born between 26 and 32 weeks gestation
Key exclusion criteria (3 listed)
- Genetic abnormality
- Neurological pathology such as intraventricular hemorrhage > grade 2
- Any medication know for altering electroencephalography recording
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 |
|---|---|---|
| electroencephalographySleep states definition by electroencephalograpy | Diagnostic test | very premature infants |
Primary outcome
Body movements evaluation during sleep
Time frame: 3 months
number of movements observed according to sleep states
3 secondary outcomes
Sleep states organization
Time frame: 3 months
Type of movements observed during sleep
Time frame: 3 months
Neurodevelopmental outcome
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
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Healthy Adult Participants
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroencephalography in people with Sleep, run by Central Hospital, Nancy, France 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 19 Aug 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body movements evaluation during sleep (time frame: 3 months). 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 19 Aug 2024.