Active clinical trials for "Respiratory Distress Syndrome, Newborn"

Hyperoxygenation for resuscitation of abnormal fetal heart rate tracings has been routine obstetric practice. However, there have not been any studies to support this practice. Recent literature have either found no associated benefit to intrapartum maternal oxygen administration, or in a number of studies demonstrated higher risk of neonatal complications. Despite these studies, the evidences have not been adequate to change the clinical practice because the majority of these studies either focused on biological differences rather than clinical outcomes data or were retrospective rather than randomized trials. Therefore, the investigators propose a large single center randomized clinical trial to determine the effects of maternal hyperoxygenation therapy for the treatment of fetal heart rate tracing abnormalities.

Acute respiratory distress syndrome (ARDS) is a form of acute lung injury of inflammatory origin, which represents a public health problem worldwide due to its prevalence, and its high mortality rate, close to 40%. Mechanical ventilation is a fundamental therapy to improve gas exchange, however, it can also induce further lung injury, a phenomenon known as ventilator induced lung injury (VILI). The limitation of tidal volume is the strategy that has shown the greatest decrease in mortality and is the cornerstone of protective ventilation. However, the respiratory rate, a fundamental parameter in the programming of the mechanical ventilator, has not been evaluated in most of the main clinical studies to date. Moreover, the natural clinical response to the use of a low tidal volume strategy is the increase in respiratory rate, which may harm the lung as it increases the energy applied to the lung parenchyma. The investigators hypothesize that the use of a lower respiratory rate, tolerating moderate hypercapnia, is associated with less VILI, measured by the release of proinflammatory mediators at the systemic level (biotrauma), compared to a conventional higher respiratory rate strategy in patients with moderate to severe ARDS. This effect is mediated by lower energy applied to the pulmonary parenchyma. To confirm this hypothesis the investigators propose a prospective cross-over clinical trial in 30 adult patients with ARDS in its acute phase, which will be randomized to two sequences of ventilation. Each period will last 12 hours, and respiratory rate (RR) will be set according to PaCO2 goal: 1) Low RR, PaCO2 60-70 mmHg; and 2) High RR, PaCO2 35-40 mmHg. Protective ventilation will be applied according to ICU standards under continuous sedation and neuromuscular blockade. Invasive systemic arterial pressure and extravascular lung water will be monitored through an arterial catheter (PICCO® system), and airway and esophageal pressures and hemodynamics continuously measured throughout the protocol. The main outcome will be Interleukin-6 in plasma. At baseline and at the end of each period blood samples will be taken for analysis, and electrical impedance tomography (EIT) and transthoracic echocardiography will be registered. After the protocol, patients will continue their management according to ICU standards.

This study is to evaluate the feasibility and safety of treatment with related donor Human Leukocyte Antigen (HLA) matched or haploidentical allogeneic T regulatory cells in patients with COVID 19 induced ARDS. Study treatment will be administered in 1 to 2 doses, with the possibility of a second infusion given 14 days after the initial infusion.

The purpose of this study is to determine whether inhaled iloprost is safe and effective in pediatric patients with pulmonary hypertension who are sick in the intensive care unit.

This pilot study was a randomized, placebo-controlled, clinical trial to test the safety of using the intravenous form of Prostaglandin E1 (PGE1) in an inhaled form for treatment of hypoxemic respiratory failure in term newborns. The study planned to enroll 50 infants diagnosed with hypoxemic respiratory failure at nine NICHD Neonatal Research Network sites, and randomly assign them to receive one dose over a 72-hour period of either high concentration PGE1 (300 ng/kg/min), low concentration PGE1 (150 ng/kg/min), or placebo (normal saline, the diluent for the drug). In addition to determining the safety, optimal dose, and duration of the therapy, this pilot trial planned to evaluate the feasibility of conducting a larger, multi-center randomized, blinded placebo-controlled trial.

This study assesses the clinical effectiveness of mammalian target of rapamycin (mTOR) inhibition with rapamycin in minimizing or decreasing the severity of acute lung injury/acute respiratory distress syndrome (ALI/ARDS) in participants infected with mild to moderate COVID-19 virus.

The study aims to evaluate the reduction in severity and progression of lung injury with three doses of lipid ibuprofen in patients with SARS-CoV-2 infections.

This study will investigate the efficacy of a novel air purification technology, Photo Electrochemical Oxidation (PECO), has on pediatric patients hospitalized for respiratory distress. The study will take place at Mercyhealth Hospital - Rockton Avenue where all 23 pediatric rooms will be outfitted with portable PECO air purifying units. The main outcomes are the length of stay and progression to ICU, which will be compared with historical controls.

Evaluate the safety, tolerability, efficacy and pharmacodynamics&pharmacokinetic properties of CT303 in patients with ARDS.

Airway pressure release ventilation (APRV) is a mode of mechanical ventilation that alternates between two levels of continuous positive airway pressure (CPAP) support and allows spontaneous respiratory effort at either CPAP level. It is considered as an alternative, life-saving modality in patients with acute respiratory distress syndrome (ARDS) that struggle for oxygenation. Compared to the classical ventilation, APRV has been shown to provide lower peak pressure, better oxygenation, less circulatory loss, and better gas exchange without deteriorating the hemodynamic condition of the ARDS patient. This mode is believed to help to achieve the target of opening consolidated lung areas (recruitment) and to prevent repeated opening-closing of alveoli (decruitment). However, there is still insufficient and limited proof to support this hypothesis. Recently, it has been proposed that early use of protective mechanical ventilation with APRV could be used preemptively to prevent development of ARDS in high risk patients. In that study, APRV prevented clinical and histological lung injury by protecting alveolar epithelial integrity, preserving surfactant and alveolar stability, and reducing pulmonary edema. The primary purpose of the present study was to investigate whether early use of APRV as a lung-protecting strategy was superior to the conventional methods in a patient population with high risk of acute respiratory distress syndrome (ARDS).