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Body Movements Analysis During Sleep in Very Premature Infants (DODOPREMA)

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ClinicalTrials.gov Identifier: NCT03432182
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Jean-Michel HASCOET, Central Hospital, Nancy, France

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Sleep Diagnostic Test: electroencephalography Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Characterization of Movements Occurring During Sleep in Very Premature Neonates: Relationship With Neurodevelopmental Outcome
Actual Study Start Date : February 28, 2018
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : December 31, 2025
Arms and Interventions
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Arm Intervention/treatment
very premature infants
Electroencephalography allowing sleep observation
 Diagnostic Test: electroencephalography
Sleep states definition by electroencephalograpy


Outcome Measures
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Primary Outcome Measures :
  1. Body movements evaluation during sleep [ Time Frame: 3 months ]
    number of movements observed according to sleep states


Secondary Outcome Measures :
  1. Sleep states organization [ Time Frame: 3 months ]
    sleep states characterization by electroencephalography according to postmenstrual age

  2. Type of movements observed during sleep [ Time Frame: 3 months ]
    Movements characterization according to sleep states

  3. Neurodevelopmental outcome [ Time Frame: 3 years ]
    neuropsychomotor evaluation by Bayley psychometric test


Eligibility Criteria
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Ages Eligible for Study:   up to 15 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants born between 26 and 32 weeks gestation

Exclusion Criteria:

  • Genetic abnormality
  • Neurological pathology such as intraventricular hemorrhage > grade 2
  • Any medication know for altering electroencephalography recording
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432182


Contacts
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Contact: Jean-Michel HASCOET, MD +33 383 342 934 j.hascoet@chru-nancy.fr
Contact: Laurelia JOURDAN +33 383 343 645 l.jourdan@chru-nancy.fr

Locations
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France
Maternity Hospital CHRU Recruiting
Nancy, France, 54035
Contact: Jean-Michel HASCOET    383342934    j.hascoet@chru-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
More Information
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Responsible Party: Jean-Michel HASCOET, Principal Investigator, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03432182    
Other Study ID Numbers: 2017-A02687-46
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jean-Michel HASCOET, Central Hospital, Nancy, France:
Premature infant
sleep state
body movement
neurodevelopmental outcome
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications