Neonate Cerebral Activity in Immediate Post Partum
NCT04225975 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-05-13
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.
Conditions
- Anoxia-Ischemia, Brain
- Neonatal Encephalopathy
Interventions
- 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
Sponsors & Collaborators
-
Centre Hospitalier Universitaire, Amiens
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- SCREENING
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Minute
- Max Age
- 15 Minutes
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-03
- Primary Completion
- 2027-01-31
- Completion
- 2027-01-31
Countries
- France
Study Locations
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