Neonate Cerebral Activity in Immediate Post Partum

NCT ID: NCT04225975

Last Updated: 2023-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-03

Study Completion Date

2024-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anoxia-Ischemia, Brain Neonatal Encephalopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Interventions

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electroencephalogram

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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

1 Minute

Maximum Eligible Age

15 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Fabrice Wallois, Pr

Role: CONTACT

(33)322087775

Jean Gondry, Pr

Role: CONTACT

(33)322087777

Facility Contacts

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Fabrice Wallois, Pr

Role: primary

(33)322087775

Jean Gondry, Pr

Role: backup

(33)322087777

Other Identifiers

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PI2019_843_0031

Identifier Type: -

Identifier Source: org_study_id

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