Clinical Trial: Analysis of the Impact of Patent Ductus Arteriosus on Brain Function in Preterm Neonates: Multimodal Approach Integrating EEG-NIRS, Ultrasound and Clinical Data
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Analysis of the Impact of Patent Ductus Arteriosus on Brain Function in Preterm Neonates: Multimodal Approach Integrating EEG-NIRS, Ultrasound and Clinical Data
Brief Summary:
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.
Detailed Summary:
Sponsor: Centre Hospitalier Universitaire, Amiens
Current Primary Outcome: change in cerebral tissue oxygenation [ Time Frame: Day 3, Day 5 , Day 12, week 5 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Centre Hospitalier Universitaire, Amiens
Dates:
Date Received: June 10, 2016
Date Started: August 2009
Date Completion: February 2017
Last Updated: December 2, 2016
Last Verified: December 2016
