- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04225975
Neonate Cerebral Activity in Immediate Post Partum (POSTPARTUM)
Evaluation of Cerebral, Hemodynamic and Neuronal Activities in Neonates in the Immediate Postpartum
Neonatal anoxia-ischemia causes significant neurodevelopmental disorders. In this study the investigators want to better understand the interactions between the nervous and the hemodynamic cerebral systems during the adaptation of the neonate to ectopic life just after birth. Birth is an at risk situation of neonatal anoxic ischemia and the lack of objective criteria for cerebral tissue oxygenation has consequences on neuronal activity. Ph cord analysis is inadequate and only indirectly reflects the state of cerebral oxygenation. Both neuronal and vascular systems are part of the same functional entity and the analysis of their interactions is likely to reveal some early malfunctions of these networks.
In this study, the investigators want to develop a multi-scale, multimodal approach that allows simultaneous interrogation of both neuronal and vascular compartments during the 15 minutes after delivery. The investigators will record, with the aid of a single sensor placed on the scalp of the child, the electroencephalogram and the cerebral tissue oxygenation. The investigators will measure interactions by means of correlation analysis between both signals.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fabrice Wallois, Pr
- Phone Number: (33)322087775
- Email: fabrice.wallois@u-picardie.fr
Study Contact Backup
- Name: Jean Gondry, Pr
- Phone Number: (33)322087777
- Email: gondry.jean@chu-amiens.fr
Study Locations
-
-
-
Amiens, France, 80054
- Recruiting
- CHU Amiens
-
Contact:
- Fabrice Wallois, Pr
- Phone Number: (33)322087775
- Email: fabrice.wallois@u-picardie.fr
-
Contact:
- Jean Gondry, Pr
- Phone Number: (33)322087777
- Email: gondry.jean@chu-amiens.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Full term neonates between 36 and 41 weeks Gestational Age
Exclusion Criteria:
- Premature neonates
- Neonates of twin pregnancy
- Suspicion of congenital malformation seen in antenatal ultrasound
- Any pathology requiring pediatric care from birth
- Newborns whose mothers had a chronic viral infection such as AIDS, hepatitis B or C, or who had a multidrug-resistant bacteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Temporal correlation with EEG
Time Frame: within the 5 minutes after birth
|
Within the 5 min after birth the electroencephalogram and the cerebral oxymetry of the neonates will be recorded with the aid of a patch on the scalp.
A multimodal approach must be developed to interrogate the dynamics and interactions of neuronal and vascular compartments, which constitute a single functional unit.
|
within the 5 minutes after birth
|
time-frequency correlation with EEG
Time Frame: within the 5 minutes after birth
|
Within the 5 min after birth the electroencephalogram and the cerebral oxymetry of the neonates will be recorded with the aid of a patch on the scalp.
A multimodal approach must be developed to interrogate the dynamics and interactions of neuronal and vascular compartments, which constitute a single functional unit.
|
within the 5 minutes after birth
|
temporal correlation with NIRS signals
Time Frame: within the 5 minutes after birth
|
Within the 5 min after birth the electroencephalogram and the cerebral oxymetry of the neonates will be recorded with the aid of a patch on the scalp.
A multimodal approach must be developed to interrogate the dynamics and interactions of neuronal and vascular compartments, which constitute a single functional unit.
|
within the 5 minutes after birth
|
time-frequency correlation with NIRS signals
Time Frame: within the 5 minutes after birth
|
Within the 5 min after birth the electroencephalogram and the cerebral oxymetry of the neonates will be recorded with the aid of a patch on the scalp.
A multimodal approach must be developed to interrogate the dynamics and interactions of neuronal and vascular compartments, which constitute a single functional unit.
|
within the 5 minutes after birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mode of delivery correlation with temporal and EEG data
Time Frame: within the 5 minutes after birth
|
Within the 5 min after birth the electroencephalogram and the cerebral oxymetry of the neonates will be recorded with the aid of a patch on the scalp.
|
within the 5 minutes after birth
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2019_843_0031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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