Neonate Cerebral Activity in Immediate Post Partum

NCT04225975 | Unknown

• 1 other identifier: PI2019_843_0031
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anoxia-Ischemia, Brain; Neonatal Encephalopathy

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Mode of delivery correlation with temporal and EEG data

  within the 5 minutes after birth

Interventions

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

Eligibility Criteria

• Age: 1 Minute - 15 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Full term neonates between 36 and 41 weeks Gestational Age

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Electroencephalography; Oximetry

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Central Study Contacts

Fabrice Wallois, Pr

CONTACT

(33)322087775; fabrice.wallois@u-picardie.fr

Jean Gondry, Pr

CONTACT

(33)322087777; gondry.jean@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 13, 2020
• Study Start: March 3, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)