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Body Movements Analysis During Sleep in Very Premature Infants

Not Applicable
Completed
Conditions
Sleep
Interventions
Diagnostic Test: electroencephalography
Registration Number
NCT03432182
Lead Sponsor
Central Hospital, Nancy, France
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
68
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
very premature infantselectroencephalographyElectroencephalography allowing sleep observation
Primary Outcome Measures
NameTimeMethod
Body movements evaluation during sleep3 months

number of movements observed according to sleep states

Secondary Outcome Measures
NameTimeMethod
Sleep states organization3 months

sleep states characterization by electroencephalography according to postmenstrual age

Type of movements observed during sleep3 months

Movements characterization according to sleep states

Neurodevelopmental outcome3 years

neuropsychomotor evaluation by Bayley psychometric test

Trial Locations

Locations (1)

Maternity Hospital CHRU

🇫🇷

Nancy, France

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