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Body Movements Analysis During Sleep in Very Premature Infants

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03432182
Acronym
DODOPREMA
Enrollment
68
Registered
2018-02-14
Start date
2018-02-28
Completion date
2024-08-15
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Keywords

Premature infant, sleep state, body movement, neurodevelopmental outcome

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.

Interventions

DIAGNOSTIC_TESTelectroencephalography

Sleep states definition by electroencephalograpy

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Days to 15 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Body movements evaluation during sleep3 monthsnumber of movements observed according to sleep states

Secondary

MeasureTime frameDescription
Sleep states organization3 monthssleep states characterization by electroencephalography according to postmenstrual age
Type of movements observed during sleep3 monthsMovements characterization according to sleep states
Neurodevelopmental outcome3 yearsneuropsychomotor evaluation by Bayley psychometric test

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026