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Clinical Trials/NCT03432182
NCT03432182
Completed
Not Applicable

Characterization of Movements Occurring During Sleep in Very Premature Neonates: Relationship With Neurodevelopmental Outcome

Central Hospital, Nancy, France1 site in 1 country68 target enrollmentFebruary 28, 2018
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ConditionsSleep

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep
Sponsor
Central Hospital, Nancy, France
Enrollment
68
Locations
1
Primary Endpoint
Body movements evaluation during sleep
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 28, 2018
End Date
August 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Principal Investigator
Principal Investigator

Jean-Michel HASCOET

Principal Investigator

Central Hospital, Nancy, France

Eligibility 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

Outcomes

Primary Outcomes

Body movements evaluation during sleep

Time Frame: 3 months

number of movements observed according to sleep states

Secondary Outcomes

  • Sleep states organization(3 months)
  • Type of movements observed during sleep(3 months)
  • Neurodevelopmental outcome(3 years)

Study Sites (1)

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