20 Clinical Trials for Various Conditions
The goal of this observational study is to determine whether a marker of dead space (the end-tidal to alveolar dead space fraction \[AVDSf\]) is more strongly associated with mortality risk than markers of oxygenation abnormality (oxygenation index) and to determine whether dead space (AVDSf) is an important marker of heterogeneity in the inhaled nitric oxide (iNO) treatment effect for children with acute respiratory distress syndrome (ARDS). The study aims are: 1. To validate AVDSf for risk stratification of mortality in pediatric ARDS 2. To determine if there is heterogeneity in treatment effect for iNO defined by AVDSf 3. To detect the association between AVDSf and microvascular dysfunction trajectory and whether iNO therapy modifies this association This is a prospective, multicenter observational study of 1260 mechanically ventilated children with moderate to severe ARDS. In a subgroup of 450 children with severe ARDS, longitudinal blood samples will be obtained to measure plasma protein markers.
The overall goal of the study is to risk stratify pediatric Acute Respiratory Distress Syndrome (ARDS) patients and to identify sub-phenotypes with shared biology in order to appropriately target therapies in future trials. This is a prospective, multicenter study of 500 intubated children with ARDS, with planned blood collection within 24 hours of ARDS onset and subsequent measurement of plasma protein biomarkers and peripheral blood gene expression.
The purpose of this study is to show that inhaled steroids in patient with PARDS can decrease the days on mechanical ventilator measured by ventilator-free days,to improve the oxygenation index (OI) or oxygenation saturation index (OSI) in patients receiving inhaled steroids and to show the relevance and feasibility of a larger study by assessing the hypothesis in a small cohort of patients. Patient will be treated for a maximum of 10 days. Secondary objectives are to reduce the length of stay (LOS) in the pediatric intensive care unit (PICU) and hospital admissions; to show less inflammation in the patients receiving inhaled steroids by measuring inflammatory markers from tracheal aspirates like Interleukin (IL6, IL8, tumor necrosis factor (TNF) α, matrix metalloproteinase8 (MMP8) and matrix metalloproteinase9 (MMP9). Lastly, to show that inhaled steroids can improve residual lung disease evaluated by Pulmonary Function Test (PFTs) and Impulse Oscillometry (IOS).
Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are devastating disorders associated with lung inflammation, low oxygen levels and respiratory failure in children. Prevalence of ALI ranges from 2.2 to 12 per 100,000 children per year. Using these estimates, up to 9,000 children each year will develop ALI/ARDS, which may cause upto 2,000 deaths per year. Currently, there are no specific therapies directed against ARDS/ALI in children. In adult patients, use of steroids early in the course of ARDS appears promising. There are no published clinical trials examining the use of steroids for the treatment of ALI/ARDS in children. Hypothesis: Subjects with ALI/ARDS receiving steroids early in the course of disease (within 72 hours) and longer than 7 days will have improved clinical outcomes as compared to placebo control group as defined by (a) a decreased duration of mechanical ventilation and (b) significantly increased PaO2/FiO2 ratios.
The purpose of this trial is to test the hypothesis that at the end of 28 days, infants and children with acute lung injury treated with prone positioning would have more ventilator-free days than those treated with supine positioning.
The goal of this observational study is to determine if Intrapulmonary Percussive Ventilation (IPV) improves lung compliance in children receiving conventional invasive mechanical ventilation. The main questions it aims to answer are: 1. Does IPV improve lung compliance 15 minutes after and 3 hours after receiving one treatment in a heterogeneous group of pediatric patients? 2. Does IPV improve lung compliance in patients with Pediatric Acute Respiratory Distress Syndrome (PARDS), and what is the degree of change compared to those without PARDS? 3. What is the effect of IPV on lung compliance according to PARDS severity (mild-moderate disease vs. severe disease). 4. What is the incidence of adverse effects of IPV? Participants will receive IPV because their medical team feels it will help their lung recovery and has already determined them to be safe candidates to receive this therapy, which is a standard airway clearance modality already routinely used in our PICU. Nothing additional will happen to participants as a result of this study. Enrolling in this study simply gives the study team permission to collect specific health information that identifies your child for research purposes, which may include results from medical tests found in their medical record and information from your child's bedside monitor and ventilator. This information will be collected before and after the IPV treatments to evaluate their response to the therapy.
The goal of this clinical trial is to perform a PEEP titration protocol and use EIT to identify the optimal PEEP at which lung overdistention and collapse are most effectively balanced. The primary and secondary aims of the study are as follows: Identify the difference between the optimal PEEP recommended by EIT metrics and the current guideline recommended approach to identifying optimal PEEP in PARDS. There will be a statistically significant difference in the recommended optimal PEEP identified using the EIT PEEP titration tool and that of the PEEP/FiO2 grid recommendations. Determine the difference in physiologic metrics between EIT optimal PEEP and the PEEP/FiO2 recommended PEEP. Participants will undergoing EIT monitoring while being subjected to PEEP titration protocol.
PISA is an ancillary study to the NIH funded clinical RESTORE Trial (U01 HL086622). This study will provide data that may allow for improved dosing recommendations in this critically ill population of children.
Severe pediatric acute respiratory distress syndrome (PARDS) is a life-threatening and frequent problem experienced by thousands of children each year. Little evidence supports current supportive practices during their critical illness. The overall objective of this study is to identify the best positional and/or ventilation practice that leads to improved patient outcomes in these critically ill children. We hypothesize that children with high moderate-severe PARDS treated with either prone positioning or high-frequency oscillatory ventilation (HFOV) will demonstrate more days off the ventilator when compared to children treated with supine positioning or conventional mechanical ventilation (CMV).
Lung units which participate in gas exchange are known as 'recruited' lung. Patients with lung injury suffer from a proportion of units which do not participate in gas exchange (i.e. the derecruited state), which results in impaired gas exchange and induces an inflammatory cascade. Currently, there is no clinical practice guideline in our intensive care unit regarding lung recruitment strategies for children with lung injury. While many studies have demonstrated efficacy (ability to open the lung) and safety of recruitment maneuvers in adults, no such studies have been performed in children. The primary purpose of this study is therefore to demonstrate the safety and efficacy of a recruitment protocol designed to maximally recruit collapsed lung in children with acute lung injury. Each study patient will follow a recruitment protocol (see Appendix 2). Two 'controls' will be utilized in this study: baseline ventilation (no recruitment maneuver) and the open lung approach (a sustained inflation followed by increased PEEP). Efficacy will be defined as an improvement in lung volume (as measured by nitrogen washout and electrical impedance tomography), and by an improvement in measured arterial partial pressure of oxygen. Safety will be defined as the incidence of barotrauma and hemodynamic consequences which occur during the protocol. A secondary purpose of this study will be to further validate electrical impedance tomography (EIT) as a non-invasive tool describing the lung parenchyma by comparing it to an accepted standard method of measuring lung volumes, the multiple breath nitrogen washout technique. Validation of EIT would allow clinicians to have a non-invasive image of a patient's lungs without the risks imposed by radiography. The information we learn will be instrumental in defining an optimal strategy for lung recruitment in children with lung injury.
Pediatric acute respiratory distress syndrome (PARDS) is a severe and diffuse lung injury that is a common cause of admission and mortality in the pediatric intensive care unit (PICU). PARDS can be secondary to many different causes, and there are few therapies that have been shown beneficial in PARDS. This study seeks to identify important PARDS subtypes using gene expression profiling of bronchial epithelial cells from control and PARDS subjects.
The overall purpose of this protocol is to identify subacute sepsis-associated cardiac disease in pediatric patients with cancer by CMR and evaluate the CMR findings during their follow-up. This will help inform heart failure management decision making. Evidence of dysfunction or elevated T2 values may inform adjustment of afterload reduction and beta blocker administration, and elevated ECV findings will suggest the need for increased surveillance for diastolic dysfunction. Primary Objectives: (Feasibility Phase) To determine the feasibility of cardiac MRI without anesthesia in the immediate post-sepsis period in children with cancer. CMR scanning will be completed within 10 days of presentation - this will allow us to ensure that possible hemodynamic or respiratory instability and renal dysfunction has resolved prior to transport to the MRI scanner during the most acute phase of illness. (Completion Phase) To estimate the frequency of subacute sepsis-associated cardiac disease, including myocardial inflammation and dysfunction, in the post-acute phase (within 10 days of presentation) of severe sepsis in children with cancer
ASCEND researchers are partnering with families of children who receive extracorporeal membrane oxygenation (ECMO) after a sudden failure of breathing named pediatric acute respiratory distress syndrome (PARDS). ECMO is a life support technology that uses an artificial lung outside of the body to do the lung's work. ASCEND has two objectives. The first objective is to learn more about children's abilities and quality of life among ECMO-supported children in the year after they leave the pediatric intensive care unit. The second objective is to compare short and long-term patient outcomes in two groups of children: one group managed with a mechanical ventilation protocol that reserves the use of extracorporeal membrane oxygenation (ECMO) until protocol failure to another group supported on ECMO per usual care.
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.
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.
To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.
This is a randomized, double-blind, placebo controlled, multicenter study to compare the efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for congenital heart defects. Eligible patients undergoing repair of a large unrestrictive ventricular septal defect (VSD), a partial or complete atrioventricular septal defect (AVSD), or an ostium primum atrial septal defect (primum ASD) will be eligible for enrollment.
The purpose of this study is to determine whether L-citrulline is effective and safe in the prevention of clinical sequelae of Acute Lung Injury in pediatric subjects undergoing surgery for congenital heart defects.
Acute lung injury (ALI) is a common, life-threatening complication among pediatric leukemia and lymphoma and hematopoietic stem cell transplant (HSCT) recipients. Although these children represent a relatively small and unique patient population, they account for the largest proportion of deaths of all pediatric diseases. The long-term goal of this project is to improve outcomes among these patients. Recently, the intratracheal administration of calfactant has resulted in decreased mortality among children with ALI including promising results among children with cancer and following HSCT. Consequently, the primary specific aim of this study is to assess the effect of calfactant on intensive care (PICU) survival among pediatric leukemia and lymphoma and HSCT patients with ALI. Secondary aims include assessment of the effect of calfactant on oxygenation and on the length of mechanical ventilation, PICU stay, and hospital stay. Calfactant therapy has been found to be of benefit in acute lung injury in the overall pediatric population by improving oxygenation and decreasing mortality. These findings, in conjunction with recent subgroup analysis in which calfactant therapy appeared to improve outcomes in immunocompromised children provide the rationale for assessing calfactant therapy in this patient population. Funding Source - FDA Office of Orphan Products Development (OOPD)
Remote Ischemic Preconditioning (RIPC) is a treatment that may be associated with improved outcomes after cardiac surgery. It can be elicited noninvasively by using a tourniquet to elicit transient ischemia over a lower extremity. It is thought to promote anti-inflammatory and cell survival pathways, and thus protect remote organs against future ischemic injury. We hypothesize that compared to sham treatment, RIPC will be associated with decreased post-operative acute kidney, myocardial, and lung injury.