NCT04225975

Neonate Cerebral Activity in Immediate Post Partum

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 1 Minute – 15 Minutes
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-03-03
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2020-01-13
• Last updated: 2023-03-22

Locations

1 site across 1 country: France