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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
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Outcomes
Full info

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

1 Minute - 15 Minutes (Child)All SexesDoes not accept healthy volunteers

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

First Posted
January 9, 2020
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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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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