Neonate Cerebral Activity in Immediate Post Partum

Neonatal Encephalopathy Clinical Trial

— POSTPARTUM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04225975
• Other study ID #: PI2019_843_0031
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2021
• Est. completion date: January 2024

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Fabrice Wallois, Pr
• Phone: (33)322087775
• Email: fabrice.wallois[@]u-picardie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 15 Minutes

Eligibility

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

Related Conditions & MeSH terms

• Anoxia-Ischemia, Brain
• Brain Diseases
• Brain Ischemia
• Hypoxia
• Hypoxia-Ischemia, Brain
• Ischemia
• Neonatal Encephalopathy

Intervention

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
• 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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within the 5 minutes after birth
Primary	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.	within the 5 minutes after birth
Primary	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.	within the 5 minutes after birth
Primary	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.	within the 5 minutes after birth
Secondary	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.	within the 5 minutes after birth