Active clinical trials for "Respiratory Distress Syndrome, Newborn"

Ventilator-induced diaphragmatic dysfunction and intensive care unit (ICU)-acquired weakness are two consequences of prolonged mechanical ventilation and critical illness in patients with acute respiratory distress syndrome (ARDS). Both complicate the process of withdrawing mechanical ventilation, increase hospital mortality and cause chronic disability in survivors. During transition from controlled to spontaneous breathing, these complications of critical illness favor an abnormal respiratory pattern and recruit accessory respiratory muscles which may promote additional lung and muscle injury. The type of ventilatory support and positioning may affect the muscle dysfunction and patient-self-inflicted lung injury at spontaneous breathing onset. In that regard, ARDS patients with ventilator-induced diaphragmatic dysfunction and ICU-acquired weakness who are transitioning from controlled to partial ventilatory support probably present an abnormal respiratory pattern which exacerbates lung and muscle injury. Physiological-oriented ventilatory approaches based on prone positioning or semi recumbent positioning with abdominal binding at spontaneous breathing onset, could decrease lung and muscle injury by favoring a better neuromuscular efficiency, and preventing intense inspiratory efforts and high transpulmonary driving pressures, as well as high-magnitude pendelluft. In the current project, in addition to perform a multimodal description of the severity of ventilator-induced diaphragmatic dysfunction and ICU-acquired weakness in prolonged mechanically ventilated ARDS patients, prone positioning and supine plus abdominal binding at spontaneous breathing onset will be evaluated.

Rationale Acute respiratory distress syndrome (ARDS) is a frequent cause of hypoxemic respiratory failure with a mortality rate of approximately 30%. The identification of ARDS phenotypes, based on focal or non-focal lung morphology, can be helpful to better target mechanical ventilation strategies of individual patients. Lung ultrasound (LUS) is a non-invasive tool that can accurately distinguish 'focal' from 'non-focal' lung morphology. The investigators hypothesize that LUS-guided personalized mechanical ventilation in ARDS patients will lead to a reduction in 90-day mortality compared to conventional mechanical ventilation.

Acute rehabilitation in critically ill patients can improve post-intensive care unit (post-ICU) physical function. Scientific evidence has considered neuromuscular electrical stimulation (NMES) as a promising approach for the early rehabilitation of patients during and/or after ICU. Neuromuscular electrostimulation can be an alternative form of muscle exercise that helps to gain strength in critically ill patients with COVID -19, due to the severe weakness that patients experience due to longer MV, analgesia and NMB duration. Thus, the general objective of evaluating the effects of an early rehabilitation protocol on the strength and functionality of patients affected by SARS-CoV-2 variants and specifically compare the effectiveness of NMES associated with the functional rehabilitation protocol(FR). Also, describe demographics, clinical status, ICU therapies, mortality estimates and Hospital outcomes, of every patients admitted in ICU during the observation periods.

This is a pilot phase, open label, non-randomized study for the treatment of ARDS in patients infected with COVID-19. Subjects will be enrolled and treated with one dose of mesenchymal stem cells and follow-up will occur 90 days post-treatment.

This is a Phase 2b, randomized, double-blind, placebo-controlled, multi-center study to assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) infusion in patients with Acute Respiratory Distress Syndrome (ARDS). This study is the extension of the Phase 1 pilot study (NCT01775774) and Phase 2a study (NCT02097641).

The scientific community is in search for novel therapies that can help to face the ongoing epidemics of novel Coronavirus (SARS-Cov-2) originated in China in December 2019. At present, there are no proven interventions to prevent progression of the disease. Some preliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could have beneficial effects on SARS-CoV-2 due to the genomic similarities between this two coronaviruses. In this study we will test whether inhaled NO therapy prevents progression in patients with mild to moderate COVID-19 disease.

The study is a prospective, randomized, controlled investigation designed for comparison of two groups for the reduction of respiratory distress in a CoViD-19 population, using gammaCore Sapphire (nVNS) plus standard of care (active) vs. standard of care alone (SoC), the control group. The gammaCore® (nVNS) treatments will be used acutely and prophylactically. The aims of this study are to summarize and compare the incidence of clinical events and pro-inflammatory cytokine levels in patients randomized to use of gammaCore Sapphire plus standard of care vs standard of care alone in patients hospitalized for CoViD-19. Secondary objectives are demonstrate the safety of gammaCore Sapphire use in patients hospitalized for CoViD-19.

This is a research study to see how safe and effective decidual stromal cells are in treating patients with respiratory failure (breathing problem where not enough oxygen is passed from the lungs into the blood) caused by COVID-19.

Very low birth weight infants are at increased risk of requiring prolonged duration of mechanical ventilation and multiple intubations, both of which are risk factors for ventilator-induced lung injury and BPD. Thus, it is important to investigate respiratory support methods that are able to effectively oxygenate and ventilate these high risk preterm infants while reducing their risk of lung injury. Nasal high-frequency ventilation is one potential intervention that may decrease the risk of respiratory failure in very low birth weight infants. Small studies have shown effective respiratory support over short time periods in infants, however these studies use nasal high-frequency oscillatory ventilation. To the investigators' knowledge there is no published studies looking at the use of nasal high-frequency jet ventilation in this high risk population. Use of non-invasive high frequency ventilation (HFV) has been described as a rescue method following failure of other non-invasive ventilator modes or as a means to increase the success post-extubation. When used as invasive high frequency ventilation, high frequency oscillatory ventilation (HFOV) or high frequency jet ventilation (HFJV) utilize supraphysiologic respiratory rates and small tidal volumes which has been shown to inflict less lung injury than conventional modes of ventilation. Using a mechanical newborn lung model, nasal HFV has improved CO2 removal when compared to conventional NIPPV. Animal studies in the lab of Kurt Albertine have shown improved ventilation and oxygenation in the high frequency nasal ventilation group versus the mechanical ventilation group in a preterm lamb model leading towards better alveolar formation noted histologically. The investigators hypothesize that extubation of very preterm infants to nHFJV will significantly decrease the rates of reintubation compared to those infants extubated to NIPPV.

This 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.