Body Movements Analysis During Sleep in Very Premature Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-28

Study Completion Date

2024-08-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Sleep

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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very premature infants

Electroencephalography allowing sleep observation

Group Type OTHER

electroencephalography

Intervention Type DIAGNOSTIC_TEST

Sleep states definition by electroencephalograpy

Interventions

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electroencephalography

Sleep states definition by electroencephalograpy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

10 Days

Maximum Eligible Age

15 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No