NCT03432182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

February 28, 2018

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

6.3 years

First QC Date

February 1, 2018

Last Update Submit

August 16, 2024

Conditions

Sleep

Keywords

Premature infantsleep statebody movementneurodevelopmental outcome

Outcome Measures

Primary Outcomes (1)

  • Body movements evaluation during sleep

    number of movements observed according to sleep states

    3 months

Secondary Outcomes (3)

  • Sleep states organization

    3 months

  • Type of movements observed during sleep

    3 months

  • Neurodevelopmental outcome

    3 years

Study Arms (1)

very premature infants

OTHER

Electroencephalography allowing sleep observation

Diagnostic Test: electroencephalography

Interventions

electroencephalographyDIAGNOSTIC_TEST

Sleep states definition by electroencephalograpy

very premature infants

Eligibility Criteria

Age10 Days - 15 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants born between 26 and 32 weeks gestation

You may not qualify if:

  • Genetic abnormality
  • Neurological pathology such as intraventricular hemorrhage \> grade 2
  • Any medication know for altering electroencephalography recording

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternity Hospital CHRU

Nancy, 54035, France

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 1, 2018

First Posted

February 14, 2018

Study Start

February 28, 2018

Primary Completion

June 30, 2024

Study Completion

August 15, 2024

Last Updated

August 19, 2024

Record last verified: 2024-08

Locations

FR(1)