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Bronchiolitis clinical trials

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NCT ID: NCT03603899 Recruiting - Clinical trials for Bronchiolitis Obliterans

Hp129 Xenon Imaging and BOS in Lung Transplantation

Start date: September 9, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The research is being conducted to develop new imaging methods that are sufficiently sensitive to allow for early diagnosis of BOS, a chronic allograft rejection affecting 50-60% of lung transplanted recipients who survive 5 years after transplant. Although lung transplantation has evolved into an effective therapeutic option for a large number of pediatric patients with end-stage pulmonary disease, long-term survival after lung transplantation is far worse than after the transplantation of other solid organs. This research may improve patient outcomes through earlier diagnosis of changes leading to BOS by obtaining image guided research biopsies of transplanted lung. Biopsies may be used for future research of ex vivo biomarkers of BOS and in the development of treatments through future clinical trials.

NCT ID: NCT03567473 Recruiting - Bronchiolitis Clinical Trials

Bronchiolitis in Infants Placebo Versus Epinephrine and Dexamethasone Study

BIPED
Start date: December 13, 2018
Phase: Phase 3
Study type: Interventional

We hypothesize that infants with bronchiolitis treated with inhaled epinephrine in the Emergency Department (ED) and a 2-day course of oral dexamethasone will have fewer hospitalizations over 7 days compared to infants treated with placebo. To examine this hypothesis, we will conduct a phase III, multicentre, randomized, double-blind trial. Infants presenting to one of twelve study EDs will be enrolled to one of two study groups: (1) inhaled epinephrine and oral dexamethasone or (2) inhaled placebo and oral placebo. Our primary outcome will be admission for bronchiolitis by day 7 following the enrolment. As a planned secondary analysis, a between-group comparison of the primary outcome will be performed in those patients presenting with a first episode of bronchiolitis.

NCT ID: NCT03528083 Completed - Bronchiolitis Clinical Trials

Pediatric Bronchiolitis Quality Improvement

Start date: May 31, 2018
Phase: N/A
Study type: Interventional

Bronchiolitis is a respiratory illness characterized by acute inflammation of the airways, typically caused by a virus. By definition, it impacts children between 2 months and 2 years of age and is the most common cause of hospitalization among infants in the first year of life (American Academy of Pediatrics). Children with this illness may exhibit respiratory distress, as well as symptoms of viral respiratory illness, such as sneezing, nasal congestion, and cough. Often, hospitalization is required for respiratory distress and to support hydration needs. Evidence based guidelines for the treatment of acute viral bronchiolitis primarily involve supportive care, which most often includes supplemental oxygen, hydration, and suctioning of secretions. However, in practice, bronchiolitis care is highly variable, often involving therapies such as inhaled bronchodilators, systemic corticosteroids, inhaled hypertonic saline, continuous pulse oximetry, chest physiotherapy, antibacterial medications, and use of intravenous fluids, all of which have been shown to be unnecessary and costly. Unnecessary care remains although multiple published quality improvement studies centered on acute bronchiolitis have proven successful. Quality improvement interventions have shown reduced use of unnecessary treatments and reduced resource allocation. Therefore, the investigators will conduct a quality improvement process to improve adherence to bronchiolitis treatment guidelines for children with bronchiolitis treated at University of California Davis Children's Hospital.

NCT ID: NCT03492307 Completed - Bronchiolitis Clinical Trials

Weight-based Flow Rates for Children With Bronchiolitis on High-Flow Nasal Cannula: A Pilot Randomized Control Trial

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

This is a pilot study comparing a weight-based high-flow nasal cannula (HFNC) protocol with the current standard HFNC protocol for children <2yo admitted to South Shore Hospital with bronchiolitis. We currently use a flat limit of 8 liters of HFNC to support work of breathing and hypoxia in these patients. We will compare that to a weight-based protocol, which will provide 2L/kg/min of flow (flows generally between 6 and 20L/minute) to this patient population. The goal of this pilot study is to assess the feasibility of our study design. We will evaluate the functionality of a new weight-based flow protocol. We will also evaluate the functionality of a new bronchiolitis scoring tool, the Bronchiolitis Assessment Severity Score (BASS), and it's ability to guide care through the new protocol. We are also testing the feasibility of recruitment, randomization and retention. We are ultimately interested in whether a weight-based flow protocol reduces need for escalation to ICU-level care for children with moderate-severe bronchiolitis on HFNC.

NCT ID: NCT03436225 Not yet recruiting - Clinical trials for Bronchiolitis; Respiratory Syncytial Virus

Steroid Therapy in Acute Bronchiolitis A New Old Line of Therapy.

Start date: February 2019
Phase: Phase 1
Study type: Interventional

The aim of the present study is to evaluate the efficacy of steroid therapy and hospital stay in patients with acute bronchiolitis at assiut university children hospital.

NCT ID: NCT03392363 Completed - Pneumonia Clinical Trials

Diagnosing Respiratory Disease in Children Using Cough Sounds 2

SMARTCOUGH-C-2
Start date: January 5, 2018
Phase:
Study type: Observational

The purpose of this prospective study is to evaluate the efficacy of the ResAppDx software application in the diagnosis of childhood acute respiratory disease, including pneumonia, bronchiolitis, asthma/reactive airways disease, croup, lower respiratory tract disease (LRTD), viral lower respiratory tract infection (vLRTI), and upper respiratory tract disease (URTD).

NCT ID: NCT03369119 Completed - Acute Asthma Clinical Trials

Effect of Addition Oral Montelukast to Standard Treatment in Acute Asthma in Hospitalized Preschool Children

Start date: August 2011
Phase: Phase 4
Study type: Interventional

Leukotriene receptor antagonists (LTRAs) are well established in the management of outpatient asthma. Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor antagonist with a rapid onset of action.However, there is very little information as to their role in acute asthma exacerbations. The purpose of this study is to determine if adding oral montelukast to the maximal standard treatment in children hospitalized for acute asthma has any additive benefit.

NCT ID: NCT03364218 Recruiting - Bronchiolitis Acute Clinical Trials

Nebulized N-Acetyl Cysteine for Bronchiolitis in Inpatient Hospital Use

Start date: February 1, 2018
Phase: Phase 4
Study type: Interventional

Bronchiolitis is the major cause of hospital admission in infants < 6 months of age and usually viruses like Respiratory syncytial virus (RSV), human metapneumo virus, Adeno virus, para-influenza virus, Rhino virus and influenza virus are the main culprit. In the US, acute bronchiolitis in infancy is responsible for approximately 150,000 hospitalizations yearly at an estimated cost of $500 million. Globally in 2005 it was estimated that at least 33.8 million were affected with RSV and in the same year, RSV associated severe acute lower respiratory infection (ALRI) were responsible for ~3.4 million hospitalizations and 66,000-199,000 deaths worldwide, with 99% of these deaths in developing countries. In acute bronchiolitis there is cellular swelling and excessive mucus production. There is also proliferation of goblet cells, which leads to increased mucus production. The excess mucus produced is poorly cleared by non-ciliated (regenerating) epithelial cells leading to areas of narrowing and blocking of the bronchioles, causing the airway obstruction, hyperinflation, increased airway resistance, atelectasis and increased ventilation-perfusion mismatch that characterize acute bronchiolitis. Currently there is no medicine that has proven effective in treating acute bronchiolitis and per American Academy of Pediatrics guidelines the management of acute bronchiolitis remains supportive care for the acute respiratory failure associated with acute bronchiolitis. N-Acetyl Cysteine (NAC) is an antioxidant, anti-mucus compound that increases intracellular glutathione at the cellular level. It cleaves disulfide bonds by converting them to two sulfhydryl groups. This action results in the breakup of mucoproteins in lung mucus, reducing their chain lengths and thinning the mucus. Nebulized NAC is not studied well in acute bronchiolitis and is uncommonly used for the same. NAC has been studied in the treatment of various disease states, including those pulmonary in nature such as cystic fibrosis, chronic bronchitis, non-cystic fibrosis bronchiectasis and found to be beneficial. With this background knowledge, the purpose of this study is to evaluate the effectiveness of nebulized mucolytic therapy in treatment of children with viral bronchiolitis.

NCT ID: NCT03362125 Completed - Bronchiolitis Clinical Trials

Bronchiolitis: Evaluation of Wang's Score as a Predictor of the Duration of Oxygen Therapy in Bronchiolitis

Start date: October 1, 2015
Phase: N/A
Study type: Observational

Evaluation of Wang's score as a predictor of the duration of oxygen therapy in bronchiolitis

NCT ID: NCT03361371 Completed - Bronchiolitis Clinical Trials

Suctioning of NOse Therapy in Bronchiolitis

SNOT
Start date: March 6, 2020
Phase: N/A
Study type: Interventional

Research Questions: Primary: In otherwise healthy infants 4 weeks to 12 months of age discharged home from the ED with acute bronchiolitis,1 is there a difference in the probability of "treatment failure" by 72 hours post discharge from the index ED visit in those receiving nasal suctioning via Zo-Li device prior to feeds compared to infants who receive nasal suctioning via bulb? Treatment failure is defined as 1) any bronchiolitis-related healthcare visit, except visits that have occurred only due to ED-recommendation at time of ED discharge or 2) the use of additional (non-study assigned) suctioning devices (see Outcome Measures section) within approximately 72 hours post discharge at the index ED visit. Hypothesis: We hypothesize that the infants who undergo scheduled nasal suctioning via ZoLi device will experience a lower treatment failure probability by approximately 72 hours post discharge from index ED visit compared to those managed by suction via a bulb. Secondary: 1. In these infants, is there a difference in the mean number of medical visits for bronchiolitis (defined as #1 under primary outcome above) within 72 hours of ED discharge? 2. In these infants, is there a difference in the mean number of unscheduled medical visits for bronchiolitis within 72 hours of ED discharge? 3. In these infants, is there a difference in the mean number of ED visits for bronchiolitis within 72 hours of ED discharge? 4. In these infants, is there a difference in the probability of a parent reporting normal/near normal feeds on approximately 72 hours discharge? 5. In these infants, is there a difference in the probability of a parent reporting normal/near normal sleeping on approximately 72 hours post ED discharge? 6. For the parent, is there a difference in the probability of a parent reporting their own normal/near normal sleeping on approximately 72 hours post ED discharge? 7. In these infants, is there a difference in the probability of parents reporting at 72 hours post ED discharge as being "very satisfied" or "satisfied" with their ability to care for their child during the study period? The sample size calculation is based on the assessment of the between-group difference in probability of treatment failure. The estimated total re-visit probability in bronchiolitis based on a recently published study was approximately 35% within 72 hours of ED discharge.49 In our pilot we have found the same rate of treatment failure. This is a superiority study in which the adoption of nasal suctioning will be recommended for future practice if the observed proportion of the primary outcome in this group is significantly lower than in the controls. With 162 patients per arm (324 in total) a two-sided test with a type I error of 0.05 will have 80% power to achieve statistical significance if suctioning reduces the probability of treatment failure from 40% to 25% (i.e. absolute reduction of 15%). This estimate is based on clinically relevant differences agreed upon by study investigators and it also represents an NNT of 7. In the Cochrane review of asthma therapies an NNT of a comparable magnitude led to a change in national practice recommendations.51 Since bronchiolitis and related medical visits are highly prevalent,20 this target difference would also have an important economic impact. Based on our previous bronchiolitis trials, the anticipated refusal rate may be 20%. Given the study design and our past experience, the study non-completion rate and loss to follow-up can safely be assumed to be no higher than 5% each. Therefore, to have complete data on 324 patients we plan to randomize 360 (i.e. 324/ (1 - 0.05) *(1 - 0.05) and to approach 450 (i.e. 360/ (1 - 0.20).