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Clinical Trials/NCT04225975
NCT04225975
Recruiting
Not Applicable

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

Centre Hospitalier Universitaire, Amiens1 site in 1 country60 target enrollmentMarch 3, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anoxia-Ischemia, Brain
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
60
Locations
1
Primary Endpoint
time-frequency correlation with EEG
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 3, 2021
End Date
January 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

time-frequency correlation with EEG

Time Frame: within the 5 minutes after birth

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

Time Frame: within the 5 minutes after birth

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

Time Frame: within the 5 minutes after birth

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 EEG

Time Frame: within the 5 minutes after birth

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 Outcomes

  • Mode of delivery correlation with temporal and EEG data(within the 5 minutes after birth)

Study Sites (1)

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