An interventional study of TFU-NIRS and NIRS in Ductus Arteriosus, Patent, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged Up to 1 Day, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-10.
Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Basic science
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.
144 studies on the registry are indexed under Ductus Arteriosus, Patent; 17 are open to participants now.
This study's enrollment of 51 is below the median of 80 across 81 interventional studies indexed under Ductus Arteriosus, Patent.
Browse Ductus Arteriosus, Patent studies →Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.
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Group of children :
Group of children :
normal group of children :
Exclusion Criteria:
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ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG)
Device: TFU-NIRS · Device: NIRS · Device: EEG
ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG)
Device: TFU-NIRS · Device: NIRS · Device: EEG
ultrasounds Transfontanellaires near-infrared spectroscopy (TFU-NIRS) near-infrared spectroscopy (NIRS) electroencephalogram (EEG)
Device: TFU-NIRS · Device: NIRS · Device: EEG
change in cerebral tissue oxygenation
Time frame: Day 3, Day 5 , Day 12, week 5
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire, Amiens