Body Movements Analysis During Sleep in Very Premature Infants

Sleep Clinical Trial

— DODOPREMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03432182
• Other study ID #: 2017-A02687-46
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2018
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Central Hospital, Nancy, France
• Contact: Jean-Michel HASCOET, MD
• Phone: +33 383 342 934
• Email: j.hascoet[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Days to 15 Days

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Sleep

Intervention

Diagnostic Test:
• electroencephalography
Sleep states definition by electroencephalograpy

Locations

Country	Name	City	State
France	Maternity Hospital CHRU	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body movements evaluation during sleep	number of movements observed according to sleep states	3 months
Secondary	Sleep states organization	sleep states characterization by electroencephalography according to postmenstrual age	3 months
Secondary	Type of movements observed during sleep	Movements characterization according to sleep states	3 months
Secondary	Neurodevelopmental outcome	neuropsychomotor evaluation by Bayley psychometric test	3 years