Neonate Cerebral Activity in Immediate Post Partum

NCT04225975 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-13

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04225975 on ClinicalTrials.gov