Analysis of the Impact of Patent Ductus Arteriosus on Brain Function in Preterm Neonates: Multimodal Approach Integrating EEG-NIRS, Ultrasound and Clinical Data

Study Overview
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Brief Summary
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This project corresponds to the main field of research of the investigators's laboratory concerning analysis of cerebral electrometabolic and haemodynamic activity in neonates. In this context, the investigators have developed know-how and specific acquisition and analysis tools (2 patents and several publications), allowing them to apply this know-how in children with patent ductus arteriosus. Patent ductus arteriosus after birth is characterized by shunting of a variable proportion of cardiac output towards the pulmonary circulation. The direct consequences of this shunting are: (i) overload of the pulmonary vasculature and left heart chambers, increasing the risk of left heart failure, haemorrhagic pulmonary oedema and late respiratory complications such as bronchopulmonary dysplasia; (ii) in contrast with the pulmonary circulation, other systemic organs are deprived of part of their normal perfusion and are subject to ischaemic hypoxia; the resulting neuronal hypoxia rapidly leads to metabolic and electrical dysfunction, the analysis of which constitutes one of the objectives of this project.

Official Title
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Analysis of the Impact of Patent Ductus Arteriosus on Brain Function in Preterm Neonates: Multimodal Approach Integrating EEG-NIRS, Ultrasound and Clinical Data

Conditions
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Ductus Arteriosus, Patent

Intervention / Treatment
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* Device: TFU-NIRS
* Device: NIRS
* Device: EEG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Group of children : meeting the age criteria having a ductus arteriosus persistence. Group of children : meeting the age criteria with persistent ductus arteriosus in the ultrasound examination for which a cardiac or respiratory treatment has already been put in place. normal group of children : meeting the age criteria without ductus arteriosus persistence ultrasound or detectable neurological disorders after clinical, neurophysiological and radiological (ETF , Scanner, MRI). Exclusion Criteria: -

Ages Eligible for Study
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Maximum Age: 1 Day

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patent ductus arteriosus<br>ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG) | Device: TFU-NIRS<br> <br> Device: NIRS<br> <br> Device: EEG<br> <br> |
| Experimental: without patent ductus arteriosus<br>ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG) | Device: TFU-NIRS<br> <br> Device: NIRS<br> <br> Device: EEG<br> <br> |
| Experimental: patent ductus arteriosus + cardiac or respiratory therapy<br>ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG) | Device: TFU-NIRS<br> <br> Device: NIRS<br> <br> Device: EEG<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in cerebral tissue oxygenation |  | Day 3, Day 5 , Day 12, week 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm neonates, EEG-NIRS