Neonate Cerebral Activity in Immediate Post Partum

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Cerebral, Hemodynamic and Neuronal Activities in Neonates in the Immediate Postpartum

Conditions
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Anoxia-Ischemia, Brain, Neonatal Encephalopathy

Intervention / Treatment
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* Diagnostic Test: electroencephalogram
* Diagnostic Test: oxymetry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 15 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: electroencephalogram|Within the 5 min after birth the electroencephalogram of the neonates will be recorded with the aid of a patch on the scalp|
|Diagnostic Test: oxymetry|Within the 5 min after birth the cerebral oxymetry of the neonates will be recorded with the aid of a patch on the scalp|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within the 5 minutes after birth | 
| 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. | within the 5 minutes after birth | 
| 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. | within the 5 minutes after birth | 
| 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. | within the 5 minutes after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within the 5 minutes after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anoxia-Ischemia, Brain, postpartum, Electroencephalography, Cerebral oxymetry, Near Infrared spectroscopy, EEG, NIRS, Neonate