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OpenTrials
Completed

NCT Number: NCT03432182

Body Movements Analysis During Sleep in Very Premature Infants

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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Key information

Conditions

Sleep Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

10 day–15 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maternity Hospital CHRU

Nancy, 54035, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electroencephalography

Diagnostic Test

Sleep states definition by electroencephalograpy

Primary outcomes

  1. Body movements evaluation during sleep

    Time frame: 3 months

    number of movements observed according to sleep states

Secondary outcomes

  1. Sleep states organization

    Time frame: 3 months

    sleep states characterization by electroencephalography according to postmenstrual age

  2. Type of movements observed during sleep

    Time frame: 3 months

    Movements characterization according to sleep states

  3. Neurodevelopmental outcome

    Time frame: 3 years

    neuropsychomotor evaluation by Bayley psychometric test

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: DODOPREMA

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Feb 14, 2018
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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