PAEAN - Erythropoietin for Hypoxic Ischaemic Encephalopathy in Newborns
Hypoxic-Ischemic EncephalopathyDouble-blind, placebo controlled Phase III trial of erythropoietin for hypoxic ischaemic encephalopathy in infants receiving hypothermia. The study aim is to determine whether Epo in conjunction with hypothermia in infants with moderate/severe hypoxic ischaemic encephalopathy (HIE) will improve neurodevelopmental outcomes at 2 years of age, without significant adverse effects, when compared to hypothermia alone.
Tolerability and Efficacy of RJX in Patients With COVID-19
COVID-19Acute Respiratory Distress Syndrome2 moreThis study is designed as a 2-part, 2-cohort, double-blind, randomized, placebo controlled, multicenter Phase 1/2 study to evaluate the safety, tolerability and efficacy of RJX in patients with COVID-19.
Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy
Hypoxic Ischemic EncephalopathyThe goal is to see whether topiramate (an anti-epileptic agent) improves the outcome of babies with neonatal hypoxic encephalopathy who are receiving whole body cooling.
Caffeine for Hypoxic-Ischemic Encephalopathy
Hypoxic-Ischemic EncephalopathyHypoxic-ischemic encephalopathy (HIE) due to perinatal asphyxia is common and often fatal. Therapeutic hypothermia reduces mortality and morbidity in infants with HIE. Even with the widespread use of therapeutic hypothermia, ~60% of infants with HIE die or have neurodevelopmental impairment. As a result, there is an urgent, unmet public health need to develop adjuvant therapies to improve survival and neurodevelopmental outcomes in this population. Caffeine may offer neuroprotection for infants with HIE by blocking adenosine receptors in the brain and reducing neuronal cell death. In animal models of HIE, caffeine reduces white matter brain injury. Drugs in the same class as caffeine (i.e., methylxanthines) have been shown to be protective against acute kidney injury in the setting of HIE. However, their safety and efficacy have not been studied in the setting of therapeutic hypothermia and their effect on neurological outcomes is not known. Since these drugs reduce injury to the kidney in infants with HIE, they may also reduce injury to the brain. This phase I study will evaluate the pharmacokinetics, safety, and preliminary effectiveness of caffeine as an adjuvant therapy to improve neurodevelopmental outcomes in infants with HIE.
Oxygen Supplementation and Ventilator Hyperinflation in the Endotracheal Suction (OSVHES)
HypoventilationHypoxemiaThis is a double crossover study where all patients are randomly allocated to one of two treatment sequences associated with endotracheal aspiration.The first treatment (A) uses two suctioning methods for each patient: one involving hyperoxygenation with administration of 100% oxygen 1 minute before and after suction (intervention I), and the other hyperoxygenation with oxygen supply to 20% above basal offer (Intervention II) in the same way.The second treatment (B) uses a technique of hyperinflation with the mechanical ventilator (PEEP-ZEEP) associated with hyperoxygenation. The intervention I, uses PEEP-ZEEP offering 20% above basal oxygenation and intervention II uses the PEEP-ZEEP with basal oxygen supply in the same way. All subjects were randomly allocated using sealed envelopes to a treatment sequence A or B on Day 1. Patients received two treatments, at least four hours apart. The first treatment is in the morning and the alternate treatment is performed in the afternoon. On Day 2 the order of the treatments was reversed using the same patient position sequence.The interventions I and II are performed at least 4 hours apart to minimize any carryover effect.
pRotective vEntilation With Veno-venouS Lung assisT in Respiratory Failure
Acute Respiratory Failure With HypoxiaThis is a trial of a new way of treating patients with respiratory failure. The investigators propose to deliver a multi-centre clinical trial to determine whether veno-venous extracorporeal carbon dioxide removal (VV-ECCO2R) and lower tidal volume mechanical ventilation improves outcomes and is cost-effective, in comparison with standard care in patients who are mechanically ventilated for acute hypoxaemic respiratory failure
Supraglottic Jet Oxygenation and Ventilation for Gastrointestinal Endoscopy at High-altitude
HypoxiaHigh AltitudeThis study aims to determine whether the use of SOJV could reduce the rate of hypoxia during gastrointestinal endoscopic procedures in deeply sedated patients sedated at high altitude comparing to the supplemental oxygen administration via nasal cannula.
Neonate Cerebral Activity in Immediate Post Partum
Anoxia-IschemiaBrain1 moreNeonatal 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.
Evaluation of the Value of 18F-Fluoromisonidazole (18F-FMISO) Positron Emission Tomography Hypoxia...
Idiopathic Pulmonary FibrosisIdiopathic pulmonary fibrosis (IPF) is a rare, chronic, lethal disease of unknown etiology and with a variable course. There is currently no test in routine care that can assess both the anatomical and functional damage of the disease at an early stage. This is the first human study in IPF to evaluate the value of a non-invasive tracer, 18F-fluoromisonidazole (18F-FMISO), targeting hypoxia in IPF patients. This is a Phase I, proof-of-concept, single-center, open-label, parallel group study. It will include 2 groups: 1 group of 10 IPF patients 1 group of 10 healthy volunteers matched to IPF patients for age and gender
Neuromuscular-Blocking Agents and Hypoxemia During Intubation in Infants (ROC-HYPOX)
HypoxemiaThe prevention of the occurrence of respiratory events is a constant concern in pediatric anesthesia, as these represent the main cause of the anesthesic mortality. These events occur partly during induction of anesthesia and are all the more frequent as the child is young. The French recommendations do not propose the use of neuromuscular-blocking agents in pediatric anesthesia. This recommendation is controversial In a recently published study, it has been shown that the use of neuromuscular blocking agents during induction in children under 2 years improves intubating conditions and reduces the incidence of hemodynamic and respiratory events. This monocentric study, centered on intubating conditions, does not allow to conclude on the influence of muscle relaxants on reduction of the respiratory morbidity. The objective of study is to demonstrate that, in children under 2 years, changing the anesthesia protocol can reduce the incidence and severity of episodes of hypoxemia associated with respiratory events occurring during induction