Body Movements Analysis During Sleep in Very Premature In... | NCT03432182

Studies
Body Movements Analysis During Sleep in Very Premature Infants

NCT03432182

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Aug 19, 2024Actual

Enrollment

68Actual

Phase

Not Applicable

Conditions

Sleep

Interventions

electroencephalography

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2018Actual

Primary Completion Date

Jun 30, 2024Actual

Completion Date

Aug 15, 2024Actual

First Submitted Date

Feb 1, 2018

First Submission Date that Met QC Criteria

Feb 7, 2018

First Posted Date

Feb 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2024

Last Update Posted Date

Aug 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jean-Michel HASCOET, Principal Investigator, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
very premature infants	Other	Electroencephalography allowing sleep observation	Diagnostic Test: electroencephalography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
electroencephalography	Diagnostic Test	Sleep states definition by electroencephalograpy	very premature infants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body movements evaluation during sleep	number of movements observed according to sleep states	3 months

Secondary Outcomes

Measure	Description	Time Frame
Sleep states organization	sleep states characterization by electroencephalography according to postmenstrual age	3 months
Type of movements observed during sleep	Movements characterization according to sleep states

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Days

Maximum Age

15 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maternity Hospital CHRU		Nancy		54035	France

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004569	Electroencephalography

Ancestor Terms

ID	Term
D003943	Diagnostic Techniques, Neurological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004568	Electrodiagnosis

Browse Leaves

Not provided

Browse Branches

Not provided