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

Primary Purpose

Sleep

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
electroencephalography
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sleep focused on measuring Premature infant, sleep state, body movement, neurodevelopmental outcome

Eligibility Criteria

10 Days - 15 Days (Child)All SexesDoes not accept 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

Sites / Locations

  • Maternity Hospital CHRURecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

very premature infants

Arm Description

Electroencephalography allowing sleep observation

Outcomes

Primary Outcome Measures

Body movements evaluation during sleep
number of movements observed according to sleep states

Secondary Outcome Measures

Sleep states organization
sleep states characterization by electroencephalography according to postmenstrual age
Type of movements observed during sleep
Movements characterization according to sleep states
Neurodevelopmental outcome
neuropsychomotor evaluation by Bayley psychometric test

Full Information

First Posted
February 1, 2018
Last Updated
January 27, 2023
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT03432182
Brief Title
Body Movements Analysis During Sleep in Very Premature Infants
Acronym
DODOPREMA
Official Title
Characterization of Movements Occurring During Sleep in Very Premature Neonates: Relationship With Neurodevelopmental Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep
Keywords
Premature infant, sleep state, body movement, neurodevelopmental outcome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
very premature infants
Arm Type
Other
Arm Description
Electroencephalography allowing sleep observation
Intervention Type
Diagnostic Test
Intervention Name(s)
electroencephalography
Intervention Description
Sleep states definition by electroencephalograpy
Primary Outcome Measure Information:
Title
Body movements evaluation during sleep
Description
number of movements observed according to sleep states
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Sleep states organization
Description
sleep states characterization by electroencephalography according to postmenstrual age
Time Frame
3 months
Title
Type of movements observed during sleep
Description
Movements characterization according to sleep states
Time Frame
3 months
Title
Neurodevelopmental outcome
Description
neuropsychomotor evaluation by Bayley psychometric test
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Days
Maximum Age & Unit of Time
15 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Michel HASCOET, MD
Phone
+33 383 342 934
Email
j.hascoet@chru-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Laurelia JOURDAN
Phone
+33 383 343 645
Email
l.jourdan@chru-nancy.fr
Facility Information:
Facility Name
Maternity Hospital CHRU
City
Nancy
ZIP/Postal Code
54035
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Michel HASCOET
Phone
383342934
Email
j.hascoet@chru-nancy.fr

12. IPD Sharing Statement

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Body Movements Analysis During Sleep in Very Premature Infants

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