Treatment Trials

136 Clinical Trials for Various Conditions

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Mite Asthma Pediatric Immunotherapy Trial
Description

The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with House Dust Mite allergic asthma based on clinically relevant asthma worsening.

Conditions

Allergic Asthma Due to Dermatophagoides Farinae, Allergic Asthma Due to Dermatophagoides Pteronyssinus, Allergic Rhinitis Due to House Dust Mite

Use of High Frequency Chest Compression in Pediatric Status Asthmaticus
Description

Asthma is a disease resulting in mucus hypersecretion and airways obstruction. This causes difficulty breathing. The High Frequency Chest Compressor (HFCC) is a device that has been shown to decrease respiratory complications in individuals with severe disability who are unable to clear airway secretions. There is a lack of studies using this device in children with asthma. The device has been shown in a study to be safe in children with asthma. The investigators propose that using this device in our pediatric patients hospitalized in the pediatric ICU with asthma will result in decreased pediatric ICU stay. The investigators will also look at asthma severity, total days of hospital stay and chest discomfort while on therapy.

Conditions

Pediatric, Asthma, Acute Exacerbation, Pediatric ICU

The Exhale Study: Treating Maternal Depression in an Urban Pediatric Asthma Clinic
Description

The goal of this clinical trial is to test the effectiveness and implementation of delivering Enhanced Brief Interpersonal Psychotherapy (IPT-B), an evidence-based maternal depression treatment, to mothers of children aged 4-11 years in an urban pediatric asthma clinic. Researchers will compare Enhanced IPT-B and supplemented usual care (brief care coordination). The main questions the trial aims to answer are: 1. Does Enhanced IPT-B decrease maternal depressive symptoms? 2. Does Enhanced IPT-B improve child asthma management and health outcomes (exacerbations, symptoms, control)? 3. What are the preliminary implementation outcomes of delivering Enhanced IPT-B in an urban pediatric asthma clinic?

Conditions

Asthma in Children, Depression

Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention
Description

The purpose of this pilot is to initiate an academic-community partnership and launch a multi-level intervention that includes an asthma exposure pathway (an online decision support and resource) and a health Promotora program that will provide culturally responsive asthma support alongside legal and medical services to improve access to asthma care and ultimately improve asthma-related outcomes in the New Haven region.

Conditions

Asthma in Children

High Flow Nasal Cannula Rates in Pediatric Asthma
Description

This is a randomized, open-label, 3-armed feasibility trial will examine conventional oxygen therapy (COT) vs high flow nasal cannula at 4L/min flow vs HFNC at 2L/kg/min flow (max 60L/min) in moderate to severe pediatric asthma exacerbations.

Conditions

Pediatric Asthma

AeviceMD for Pediatric Asthma Management
Description

A wearable remote patient monitor (AeviceMD) is to be used to monitor the respiratory health of pediatric asthma patients in this pilot study. Patients prescribed with AeviceMD should be able to gain better control over their disease during home management. Physicians should be able to optimize treatment for these patients using objective data collected from and of these patients outside of the clinic. The AeviceMD should also be used as a remote auscultation device for teleconsultations.

Conditions

Asthma, Asthma in Children, Pediatric Asthma, Chronic Respiratory Disease

Evaluation of a Remote Asthma Monitoring Program to Improve Health Outcomes in Pediatric Asthma
Description

The primary objective of this pilot study to is to determine the overall impact of a clinical program of remote medication monitoring administered by St. Mary's Homecare on disease control in pediatric asthma patients. The central hypothesis is that a short-term program of remote asthma medication monitoring paired with home visits and asthma education will be associated with a sustained improvement in asthma symptom control in children over time.

Conditions

Asthma in Children

vDOT for Newly Diagnosed Pediatric Asthma
Description

The goal of this research study is to compare the impact of video directly observed therapy on inhaler technique accuracy with participants receiving video directly observed therapy vs. participants receiving standard asthma care. Participants will be randomized between the two groups. We will follow up and compare the two groups to see if they have improved asthma control as measured by symptom-free days (SFD), higher inhaler technique at 3-month follow up, higher checklist scores on a standardized inhaler technique checklist, higher proportion of days covered (PDC) of their inhaled asthma controller medication, and have fewer acute care visits for asthma.

Conditions

Asthma in Children

Using Social Media to Decrease Healthcare Utilization for Pediatric Asthma
Description

The purpose of this study is to evaluate if social media enhanced education (SME) will reduce total number of treatment days defined as summation of days of subsequent hospital admission, emergency room visits, and clinic visits, reduce missed school days, reduce total costs from a health system perspective, have increased effect with increased social media engagement, have increased effect in participants with both caregiver and patient (combined) with social media accounts, compared to participants where only the patient or only the caregiver uses social media (single),have increased patient satisfaction in the asthma education received and to obtain the experience and data needed to refine SME to be able to expand this platform for other chronic medical conditions with high healthcare utilization including pediatric diabetes, epilepsy, and sickle cell disease in children with asthma.

Conditions

Asthma in Children

A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3)
Description

This is a randomized, double-blind, placebo-controlled, crossover study comparing asthma control post treatment in African American/Black and Caucasian/White children in both hyper and hypo responsive HILD (Histamine Lontophoresis with Laser Doppler monitoring) phenotypes with uncontrolled persistent allergic asthma using Levocetirizine (LTZ) vs placebo.

Conditions

Allergic Asthma

Implementing Pathways to Improve Pediatric Asthma Care
Description

Background: Asthma affects nearly 10% of American children, and is a leading cause of pediatric emergency visits and hospitalizations. Clinical pathways are operational versions of practice guidelines aimed at the hospital management of common illnesses. Single-site studies of pediatric asthma pathways have shown significant improvements in quality of care. Primary Objective: To evaluate the effectiveness of clinical pathways for improving quality of care for children with asthma in a diverse, national sample of emergency department (ED) and hospital settings. Primary Endpoints: 1. Emergency Department: The proportion of eligible children who receive systemic steroids within 60 minutes of ED arrival 2. Inpatient/Hospital: Mean length of hospital stay Study Design: This project will be implemented through an established quality improvement collaborative of hospitals across the United States, the Value in Inpatient Pediatrics Network (part of the American Academy of Pediatrics). A cluster randomized design will be employed. Group 1 hospitals will receive a multifaceted implementation strategy that includes: 1) a pathway implementation toolkit, 2) local multidisciplinary champions in the ED and inpatient settings, 3) audit and feedback, 4) educational seminars, and 5) practice facilitation (via teleconference). Group 2 will receive the same intervention with the addition of a mobile app pathway tool.

Conditions

Asthma

Pediatric ASTHMA-Educator
Description

This project seeks to develop and pilot test the pediatric ASTHMA-Educator mobile application.

Conditions

Asthma

Inhaled Steroids for Pediatric Asthma at Pediatric Emergency Medicine Discharge
Description

This study evaluates the initiation of inhaled corticosteroids upon discharge from the pediatric emergency room in children under 18 presenting with asthma exacerbation. Half of the patients will receive a prescription for inhaled corticosteroids in addition to standard care, and half of the patients will receive standard card alone.

Conditions

Asthma, Pediatric ALL

Factors Influencing Pediatric Asthma
Description

Asthma is a chronic lung disease with serious morbidity and potential mortality. Multiple physiologic, environmental and social conditions impact the prevalence and severity of asthma. Even when diagnosed, effective control can be impeded by improper use of medication, not understanding or being unable to avoid environmental triggers, lack of continuity in follow-up care, and lack of an asthma action plan. American Indians are especially at-risk for health problems related to asthma. American Indians have the highest asthma rate among single-race groups; 18.5% of American Indians are diagnosed with asthma, while only 11% are diagnosed with asthma in the general population but little is known about why this is true. Asthma is a prototypic example of the interaction of biologic, environmental and psychosocial influences on disease and this study investigated the possible improvement in asthma control from an intensive educational intervention.

Conditions

Asthma in Children

RVA Breathes: A Richmond City Collaboration to Reduce Pediatric Asthma Disparities
Description

The goal of this study is to evaluate a sustainable, community-engaged program to reduce asthma disparities among 5 to 11-year-old children in Richmond, Virginia. Richmond, an urban center, has been named the Asthma Capital, or "most challenging place to live in the U.S. with asthma," by the Asthma and Allergy Foundation three times in the last 5 years. To date, however, the city has no comprehensive, community-engaged asthma care program for those children at highest risk for poor asthma outcomes. To address this disparity, the study team engaged with community partners and completed a mixed-methods needs assessment to enhance understanding of the barriers and supports to asthma care for children and their families living in Richmond. Several key priority areas emerged: peer support, advocacy, treating the home as a system, increased school nurse education, and coordination with schools and providers. Working together, the community-engaged team translated needs assessment findings to RVA Breathes, a program coordinating asthma care across 4 sectors: family, home, community, and medical care.

Conditions

Asthma

Text2Breathe: Enhance Parent Communication to Reduce Pediatric Asthma Disparities
Description

Text2Breathe (T2B) is a randomized controlled trial aimed at improving communication between parents and their children's' primary care providers about asthma. The overarching goal of this study is to reduce disparities among a population with high rates of pediatric asthma morbidity. The investigators are testing the efficacy of a short message service (SMS)-enhanced health communication (HC) intervention ("Text2Breathe") designed to equip urban, low-income parents with tools for communicating effectively with their children's primary care provider (PCP).

Conditions

Asthma

A Computer-Based ED Intervention to Improve Pediatric Asthma Medicine Adherence
Description

Asthma is common in children and impacts their health. There are effective medications for improving asthma, but some families have difficulty using medicines on a regular basis. This study in the emergency department will improve medicine use for children 2-12 years-old with asthma by developing content for a customized, tablet-based electronic intervention. A clinical trial will then be used to compare asthma outcomes for this intervention with routine asthma care.

Conditions

Asthma

Comparison of Vibrating Mesh Nebulizer Versus Jet Nebulizer in the Pediatric Asthma Patient
Description

The purpose of this study is to compare clinical outcomes related to the current practice of using a jet nebulizer (JN) with aerosol mask (AM) or mouthpiece (MP) versus a vibrating mesh nebulizer (VMN) with a valved-mask (VM) or MP in the treatment of acute moderate to severe asthma in Children's Medical Center Dallas Emergency Department (CMCED).

Conditions

Asthma

Trial of One Versus Two Doses of Dexamethasone for Pediatric Asthma Exacerbation
Description

Comparing one versus two doses of oral dexamethasone for the treatment of asthma in the pediatric emergency department.

Conditions

Asthma

Using Question Prompt Lists During Pediatric Asthma Visits to Increase Adolescent Involvement
Description

The purpose of this study is to conduct a randomized controlled trial with English and Spanish-speaking adolescents to compare the effectiveness of an adolescent "asthma question prompt list" with a supportive educational video intervention with usual care. The hypothesis of this study is that by showing the parents and adolescents the educational video and then providing the adolescents with the one-page "asthma question prompt lists" to use during their visits will improve: (a) asthma control, (b) adolescent self-efficacy in managing asthma, and (c) adolescent quality-of-life.

Conditions

Asthma

The Effects of Music Therapy as a Complementary Intervention in the Treatment of Pediatric Asthma
Description

The onset of asthma is particularly frightening for children. When the symptoms of asthma decrease, children and parents forget about the maintenance and control of breath and lung volume. Because adherence is so poor, asthma is known as the emergency room illness. The playing of a wind instrument is a unique way to provide a creative means for children and teens to understand both the impact of diaphramatic breathing and their ability to control it as well. This study builds upon the evidence, though sparse, that suggest that the blowing of a wind instrument with clinical music therapy intervention strengthens the muscles of breathing and fortifies the incentive toward attending to the daily symptoms and general management of asthma.

Conditions

Asthma

Use of Dexamethasone in Pediatric Asthma Exacerbations
Description

The purpose of this study is to compare the efficacy of a single dose of dexamethasone vs. two doses of dexamethasone in mild and moderate asthma exacerbations pediatric patients.

Conditions

Asthma

A Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler in Pediatric Asthmatics
Description

The study is to evaluate the chronic-dose efficacy and the safety of Albuterol MDPI compared to placebo in pediatric participants with asthma.

Conditions

Asthma

Vitamin D in Pediatric Asthma: a Randomized Controlled Open-label Pilot Trial
Description

This is a pilot randomized controlled trial of lower vs. higher dose vitamin D supplementation in D-deficient asthmatic children, to determine necessary sample sizes for outcome measures in a larger multisite study, and to examine possible relationships and effect sizes between various biological markers that may be important to the pathophysiology of childhood asthma. Aims of the study are to: 1. Evaluate effect sizes for relationships between serum 25OH-vitD and omega-fatty acid (FA) biomarkers, before and after supplementation with lower or higher dose vitamin D, on immune function, and asthma severity. 2. Characterize changes in innate and adaptive immune function and inflammatory responses in asthmatic D-deficient youth at baseline and after vitD supplements, by dietary O6:O3FA status and vitD dose.

Conditions

Asthma, Vitamin D Deficiency

Comparison of Nebulizers in ED in Pediatric Asthma Patients
Description

The primary objective will be, in an open-label randomized trial, a comparison of emergency department (ED) length of stay (LOS) between children experiencing acute asthma treated with two different nebulizers. Secondary outcomes will include admission rates, hospital LOS, need for additional therapies, transfers to a higher level of care, side-effects, and unscheduled return visits

Conditions

Asthma

Adaptation of the Pediatric Asthma Control & Communication Instrument (PACCI) in a Pediatric Emergency Department
Description

This study examined whether the Pediatric Asthma Control and Communication Instrument for the Emergency Department (PACCI-ED), a 12-item questionnaire, can help doctors in the emergency department accurately assess a child's asthma control. This study involved an intervention with the doctors in the emergency department of an urban pediatric hospital. The intervention was done when one of the doctors involved in the study treated a child aged 1-17 years for an asthma exacerbation. Parents answered questions on the PACCI-ED about their children's asthma. Half of the doctors were allowed to see the PACCI-ED results and half were not. The two groups of doctors were compared on their ability to correctly identify asthma control categories, whether a child's asthma was worsening or improving, whether the family was administering controller medications as often as they should, and how much burden the child's asthma was for the family.

Conditions

Asthma

Evaluation of a Shared Decision Making Portal for Pediatric Asthma
Description

This pilot intervention study will test the feasibility and acceptability and explore the outcomes of a primary care-based shared decision making (SDM) electronic medical record (EMR)-based portal that provides education, elicits and tracks patients/families' treatment concerns and goals, assesses symptoms and asthma control over time, and provides decision support to clinicians and families.

Conditions

Asthma

Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation
Description

Project Aim: To determine if intramuscular epinephrine is an effective adjunct to inhaled bronchodilators (β2 agonists) for children with severe asthma exacerbation. Hypothesis: IM epinephrine is an efficacious adjunct to inhaled bronchodilators (β2 agonists) for children with severe asthma exacerbation. Intervention: Subjects will be randomly assigned (50% chance) to receive a weight based dose of IM epinephrine 1:1000 or no adjunctive medication. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle. In addition to the study intervention, the standardized treatment pathway based on the current asthma guidelines in use at the investigator's center will be utilized. This pathway includes nebulized albuterol, ipratropium bromide, and systemic corticosteroids. The duration and dosages of these other interventions will be administered at the discretion of the treating provider.

Conditions

Asthma

A Pilot Study of Personalized Medicine for Pediatric Asthma
Description

A pilot study to test the feasibility of a personalized asthma care intervention.

Conditions

Asthma

Pilot Study of Magnesium Infusions in Pediatric Asthma
Description

This is a prospective randomized pilot study that seeks to address the research question: In children with moderate-to-severe asthma, do intravenous magnesium infusions added to standard Pediatric intensive care unit (PICU)-level asthma care significantly decrease time from patient presentation until PICU discharge?

Conditions

Asthma