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Neonate Cerebral Activity in Immediate Post Partum (POSTPARTUM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04225975
Recruitment Status : Not yet recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.


Condition or disease Intervention/treatment Phase
Anoxia-Ischemia, Brain Neonatal Encephalopathy Diagnostic Test: electroencephalogram Diagnostic Test: oxymetry Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evaluation of Cerebral, Hemodynamic and Neuronal Activities in Neonates in the Immediate Postpartum
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care


Intervention Details:
  • 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
  • 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


Primary Outcome Measures :
  1. Temporal correlation with EEG [ Time Frame: within the 5 minutes after birth ]
    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.

  2. time-frequency correlation with EEG [ Time Frame: within the 5 minutes after birth ]
    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.

  3. temporal correlation with NIRS signals [ Time Frame: within the 5 minutes after birth ]
    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.

  4. time-frequency correlation with NIRS signals [ Time Frame: within the 5 minutes after birth ]
    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.


Secondary Outcome Measures :
  1. Mode of delivery correlation with temporal and EEG data [ Time Frame: within the 5 minutes after birth ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04225975


Contacts
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Contact: Fabrice Wallois, Pr (33)322087775 fabrice.wallois@u-picardie.fr
Contact: Jean Gondry, Pr (33)322087777 gondry.jean@chu-amiens.fr

Locations
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France
CHU Amiens
Amiens, France, 80054
Contact: Fabrice Wallois, Pr    (33)322087775    fabrice.wallois@u-picardie.fr   
Contact: Jean Gondry, Pr    (33)322087777    gondry.jean@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT04225975    
Other Study ID Numbers: PI2019_843_0031
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Anoxia-Ischemia, Brain
postpartum
Electroencephalography
Cerebral oxymetry
Near Infrared spectroscopy
EEG
NIRS
Neonate
Additional relevant MeSH terms:
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Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Ischemia
Hypoxia
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms, Respiratory
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain