Neonate Cerebral Activity in Immediate Post Partum

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-15
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Full term neonates between 36 and 41 weeks Gestational Age

Disqualifiers

Premature neonates

Neonates of twin pregnancy

Suspicion of congenital malformation seen in antenatal ultrasound

Any pathology requiring pediatric care from birth

Trial design

Design model

Single group

Treatments tested in this trial

  • electroencephalogram

    Diagnostic test

    Within the 5 min after birth the electroencephalogram of the neonates will be recorded with the aid of a patch on the scalp

  • oxymetry

    Diagnostic test

    Within the 5 min after birth the cerebral oxymetry of the neonates will be recorded with the aid of a patch on the scalp

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
within the 5 minutes after birth
2

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.

Time frame
within the 5 minutes after birth
3

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.

Time frame
within the 5 minutes after birth
4

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.

Time frame
within the 5 minutes after birth

Secondary outcomes

1

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.

Time frame
within the 5 minutes after birth

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.