Active clinical trials for "Respiratory Distress Syndrome, Newborn"

Barotrauma (pneumothorax, pneumomediastinum) is a well-described complication of Acute Respiratory Distress Syndrome (ARDS), especially in patients with coronavirus disease 2019 (COVID-19) (16.1% in COVID-19, and about 6% in non-COVID-19 ARDS). Macklin effect was recently discovered by our group as an accurate radiological predictor of barotrauma in COVID-19 ARDS; the Investigators also found that density histograms automatically extracted from chest CT images provide a reliable insight into lung composition . Since lung frailty is a major issue also in non-COVID-19 ARDS, the Investigators want to confirm the predictive role of Macklin effect also in this setting. In addition, the Investigators aim to explore inflammatory profiling to decipher different biological aspects of the same clinical issue. Finally, the Investigators want to develop a specific management algorithm for patients diagnosed, according to our findings, with a specific ARDS sub phenotype characterized by increased lung frailty

Mechanical respiratory support of preterm neonates with respiratory distress syndrome (RDS) and/or apnoea of prematurity (AOP) might be associated with adverse effects due to positive pressure (barotrauma), excessive gas delivery (volutrauma) or inadequate volume (atelectrauma). Asynchrony between patient efforts and ventilator support increases patient discomfort, favouring "fighting" the machine, and increases the risk of air trapping and lung overdistension even in patients with non-invasive ventilation (NIV). Recently, a new modality of synchronization has been available for pediatric and neonatal use: the neurally adjusted ventilatory assist (NAVA), which uses the diaphragmatic electrical activity (Edi) as a signal to start the rise in pressure of the ventilator, and to adjust the tidal volume and the inspiratory time (cycling off) to the patient needs, breath by breath. The aims of this study are to know whether NIV-NAVA compared to unsynchronized modalities (nCPAP/nIPPV), in infants born < 32 weeks GA with respiratory distress syndrome or requiring prophylactic NIV (immaturity, apnoea) reduces systemic inflammation, measured by serum cytokines concentration, reduces the need for oxygen and respiratory support, and if it increases the probabilities of survival without bronchopulmonary dysplasia (BPD).

In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via nasal CPAP, and needing surfactant treatment will be randomized to standard delivery of surfactant via and endotracheal tube airway(inserted after pre-medication for pain), or to surfactant delivery via laryngeal mask airway (LMA). The intent is to remove the airways and return babies to nasal CPAP, after surfactant is given. The primary outcome measure is the rate of failure of initial surfactant therapy. Standardized failure criteria are reached: a) early, if the baby is unable to be placed back on CPAP (needs mechanical ventilation) or, b) late, if the baby requires retreatment with surfactant within 8 hours or more than 2 doses of surfactant. The objective of this protocol is to reduce the need for endotracheal intubation and mechanical ventilation in preterm neonates with RDS needing rescue surfactant therapy by instilling surfactant though an LMA, while achieving comparable efficacy of surfactant treatment. The hypothesis is that surfactant treatment through an LMA will decrease the proportion of babies with RDS who require mechanical ventilation or subsequent intubation, when compared with standard surfactant treatment following sedation and endotracheal intubation.

This Phase I/IIa, multi-center, randomized, placebo-controlled, single-blinded dose-escalation study evaluated TNX-832 (also referred to as ALT-836 and Sunol cH36) in subjects with suspected or proven bacteria-induced ALI/ARDS. Up to five cohorts of at least six subjects each were originally planned. Subjects were to be randomized in a 5:1 ratio to receive TNX-832 or placebo,respectively, administered as a single bolus infusion over 15 minutes. Three cohorts of subjects were enrolled to the study and safety and pharmacokinetics of the study treatment were evaluated.

Transfusion-related acute lung injury (TRALI) is the most common cause of transfusion-related morbidity and mortality in the United States. It is very common and often unrecognized in the critically ill with the greatest incidence occurring in bleeding patients with liver disease. Plasma is the most blood component associated with this deadly complication and therefore patients with liver disease who frequently receive transfused plasma are at increased risk. The optimal plasma transfusion strategy for bleeding patients with liver disease is unknown and the investigators will evaluate this clinical question in a small pilot randomized controlled trial. The invstigators hypothesize that targetting a more restrictive INR Target (2.5) vs. an INR Target (1.8) will result in less hypoxemia, a TRALI surrogate without increasing bleeding complications.

People with acute respiratory failure usually require the use of an artificial breathing machine, known as a mechanical ventilator. Sedative medications, which help keep people calm and reduce anxiety, are often prescribed for children who are on mechanical ventilators. However, the longer that sedative medications are used, the longer a child may need to remain on mechanical ventilation. This study will evaluate the effectiveness of a team approach to sedation management that aims to reduce the number of days that children with acute respiratory failure require mechanical ventilation.

Title of Study: A Prospective, Randomized, Multicenter Trial Comparing Synchronized Intermittent Mandatory Ventilation (SIMV) vs. Early Extubation to Nasal Intermittent Positive Pressure Ventilation (NIPPV) after Surfactant Treatment in Preterm Infants with Respiratory Distress Treatment Period (Planned): 7 days Objectives: To compare the impact of early extubation [within 120 minutes of birth to Nasal Intermittent Positive Pressure Ventilation (NIPPV group) vs. Synchronized Intermittent Mandatory Ventilation (SIMV group) on the incidence of mechanical ventilation via endotracheal tube at 7 days of age in 26 to 29 + 6 weeks gestation premature infants with respiratory distress treated with intratracheal Curosurf (poractant alpha) within 60 minutes of birth. Secondary objectives include evaluation of overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age (PMA) and/or at discharge, complications, safety, and adverse events. Number of Subjects: 110

Hypothesis: Extracorporeal removal of CO2 can treat hypercapnia and respiratory acidosis, which allows application of lung protective ventilation. This downgrading of mechanical ventilation promotes better and more quickly lung recovery. Aim: The aim of the study is to treat respiratory acidosis and to reduce plateau pressures by using an extracorporeal removal of CO2 (ECCO2-R). This prospective study will include 10 patients with an Acute Respiratory Distress Syndrome (ARDS). ARDS is an inflammatory response in the lungs, the onset is acute with pulmonary oedema and shows bilateral densities on chest radiography. The take up of oxygen and the loss of CO2 in the lungs are difficult. Moreover the patient's blood can become acidic due to too much CO2. To promote a better gas-exchange, the patient with ARDS will be mechanically ventilated. This can be aggressive and harmful for the lungs. With the use of an extra-corporeal CO2-remover, CO2 can be removed so that the mechanical ventilation setting will be less aggressive and will decrease lesions in the lung. The veno-venous extracorporeal CO2-remover pumps blood from a vein via a catheter through an oxygenator (gas exchanger that adds oxygen to the blood and extracts carbon dioxide from the blood) and back into a vein. The investigators will use a standard dialysis catheter that will be put in a large vein. To prevent clotting of the system, the patient will receive heparin. In the study the investigators will work in periods of two hours, the situation before and after carbon dioxide removal will be compared. With this study the investigators want to prove that the CO2 in the blood decreases with at least 20 % with the use of the extracorporeal CO2 remover. More over the investigators want to prove that lower mechanical ventilation settings (thanks to CO2-removal by the ECCO2-R) will produce fewer lesions to the lungs.

Infants showing high local pulmonary inflammation diagnosted by respiratory distress syndrome usually need the second or more pulmonary surfactant and is easier to developing to Brochopulmonary. Cursurf is used worldwide in infants with respiratory distress syndrome, Budesonide is a glucocorticoid with a high local anti-inflammatory effect.Our hypothesis is Cursurf combined with Budesonide could reduced the need of Cursurf and incidence of Brochopulmonary dysplasia.

This is a randomized, double-blind, placebo-controlled, single ascending (SAD), and multiple ascending dose (MAD) study conducted at a single clinical site within the UK. Healthy male and female subjects (on non-child bearing potential) will be enrolled to investigate single inhaled doses of molgramostim at 3 dose levels (Part 1) and multiple inhaled doses at 2 dose levels (Part 2). The 2 doses in the multiple ascending dose regimens will be administered once daily (QD) for 6 consecutive days. The clinical indication for inhaled molgramostim is the treatment of respiratory diseases such as aPAP, bronchiectasis and cystic fibrosis. The Clinical trial will involve 42 healthy participants. The trial is expected to last approximately 4 months.