Neonate Cerebral Activity in Immediate Post Partum (POSTPARTUM)
Primary Purpose
Anoxia-Ischemia, Brain, Neonatal Encephalopathy
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
electroencephalogram
oxymetry
Sponsored by
About this trial
This is an interventional screening trial for Anoxia-Ischemia, Brain focused on measuring Anoxia-Ischemia, Brain, postpartum, Electroencephalography, Cerebral oxymetry, Near Infrared spectroscopy, EEG, NIRS, Neonate
Eligibility Criteria
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
Sites / Locations
- CHU AmiensRecruiting
Outcomes
Primary Outcome Measures
Temporal correlation with EEG
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.
time-frequency correlation with EEG
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.
temporal correlation with NIRS signals
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.
time-frequency correlation with NIRS signals
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.
Secondary Outcome Measures
Mode of delivery correlation with temporal and EEG data
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.
Full Information
NCT ID
NCT04225975
First Posted
January 9, 2020
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT04225975
Brief Title
Neonate Cerebral Activity in Immediate Post Partum
Acronym
POSTPARTUM
Official Title
Evaluation of Cerebral, Hemodynamic and Neuronal Activities in Neonates in the Immediate Postpartum
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anoxia-Ischemia, Brain, Neonatal Encephalopathy
Keywords
Anoxia-Ischemia, Brain, postpartum, Electroencephalography, Cerebral oxymetry, Near Infrared spectroscopy, EEG, NIRS, Neonate
7. Study Design
Primary Purpose
Screening
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
Intervention Type
Diagnostic Test
Intervention Name(s)
electroencephalogram
Intervention Description
Within the 5 min after birth the electroencephalogram of the neonates will be recorded with the aid of a patch on the scalp
Intervention Type
Diagnostic Test
Intervention Name(s)
oxymetry
Intervention Description
Within the 5 min after birth the cerebral oxymetry of the neonates will be recorded with the aid of a patch on the scalp
Primary Outcome Measure Information:
Title
Temporal correlation with EEG
Description
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.
Time Frame
within the 5 minutes after birth
Title
time-frequency correlation with EEG
Description
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.
Time Frame
within the 5 minutes after birth
Title
temporal correlation with NIRS signals
Description
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.
Time Frame
within the 5 minutes after birth
Title
time-frequency correlation with NIRS signals
Description
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.
Time Frame
within the 5 minutes after birth
Secondary Outcome Measure Information:
Title
Mode of delivery correlation with temporal and EEG data
Description
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.
Time Frame
within the 5 minutes after birth
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
15 Minutes
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrice Wallois, Pr
Phone
(33)322087775
Email
fabrice.wallois@u-picardie.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Gondry, Pr
Phone
(33)322087777
Email
gondry.jean@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice Wallois, Pr
Phone
(33)322087775
Email
fabrice.wallois@u-picardie.fr
First Name & Middle Initial & Last Name & Degree
Jean Gondry, Pr
Phone
(33)322087777
Email
gondry.jean@chu-amiens.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Neonate Cerebral Activity in Immediate Post Partum
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