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Neonate Cerebral Activity in Immediate Post Partum

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04225975
Acronym
POSTPARTUM
Enrollment
60
Registered
2020-01-13
Start date
2021-03-03
Completion date
2027-01-01
Last updated
2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anoxia-Ischemia, Brain, Neonatal Encephalopathy

Keywords

Anoxia-Ischemia, Brain, postpartum, Electroencephalography, Cerebral oxymetry, Near Infrared spectroscopy, EEG, NIRS, Neonate

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.

Interventions

DIAGNOSTIC_TESTelectroencephalogram

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

DIAGNOSTIC_TESToxymetry

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

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Temporal correlation with EEGwithin the 5 minutes after birthWithin 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 EEGwithin the 5 minutes after birthWithin 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 signalswithin the 5 minutes after birthWithin 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 signalswithin the 5 minutes after birthWithin 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

MeasureTime frameDescription
Mode of delivery correlation with temporal and EEG datawithin the 5 minutes after birthWithin 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.

Countries

France

Contacts

CONTACTFabrice Wallois, Pr
fabrice.wallois@u-picardie.fr(33)322087775
CONTACTJean Gondry, Pr
gondry.jean@chu-amiens.fr(33)322087777

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026