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

Central Hospital, Nancy, France

Status: Completed

Conditions: Sleep

Treatments: Diagnostic Test: electroencephalography

Study type: Interventional

Funder types: Other

Identifiers

NCT03432182

2017-A02687-46

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 10 to 15 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 1 patient group

very premature infants

Other group

Description:

Electroencephalography allowing sleep observation

Treatment:

Diagnostic Test: electroencephalography