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

February 7, 2024 updated by: Jean-Michel HASCOET, Central Hospital, Nancy, France

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Nancy, France, 54035
        • Recruiting
        • Maternity Hospital CHRU
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 2 weeks (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: very premature infants
Electroencephalography allowing sleep observation
Diagnostic test: electroencephalography
Sleep states definition by electroencephalograpy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep states organization
Time Frame: 3 months
sleep states characterization by electroencephalography according to postmenstrual age
3 months
Type of movements observed during sleep
Time Frame: 3 months
Movements characterization according to sleep states
3 months
Neurodevelopmental outcome
Time Frame: 3 years
neuropsychomotor evaluation by Bayley psychometric test
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2018

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 1, 2018

First Submitted That Met QC Criteria

February 7, 2018

First Posted (Actual)

February 14, 2018

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A02687-46

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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