Clinical Research Directory

Evaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma

This study evaluates the diagnostic performance, usability, and clinical utility of the Medentum Diagnostik platform, a multisensor device with integrated software and artificial intelligence, in pediatric patients with asthma and ENT conditions. Participants will be assigned to either home-based use of the Diagnostik platform with telehealth-supported clinician evaluation or standard in-person care. The primary objective is to assess agreement between AI-generated diagnoses and clinician diagnoses obtained during study encounters, including telehealth evaluations in the Diagnostik arm and in-person evaluations in the standard-of-care arm. Secondary objectives include evaluating agreement between AI-generated diagnoses and independent research team diagnoses, as well as assessing usability, patient and caregiver satisfaction, healthcare utilization, and clinical outcomes such as asthma control and symptom resolution. This study will also evaluate differences in healthcare utilization, including in-person visits, emergency care use, and time to diagnosis and treatment, between study groups.

Humidity Asthma Interventions for Low Socioeconomic Status Children

The goal of this intervention study is to assess the effectiveness of low-cost humidity and mold reduction interventions in the home for reducing pediatric asthma. The study will have two groups, a treatment group that receives the healthy home interventions during the study and a second control group that will receive these after the study. We will compare pediatric asthma before and three months after the healthy home interventions are performed.

Modern Technologies in Lower Respiratory Tract Infections in Children

Lower respiratory tract infections (LRTIs) are a significant cause of childhood morbidity and mortality globally, particularly in low-income countries. In Norway, LRTIs is a leading cause of hospitalization among infants, representing a great socioeconomic burden. Bronchiolitis, a viral infection, is the main representation of LRTIs in infants. It affects the small airways, causing breathing- and feeding difficulties. Today, treatment relies on subjective evaluations, lacking objective measures for assessment. This increases the risk of both under- and over treating patients. In the long term, bronchiolitis increases risk of asthma, but it is unknown who the high-risk patients for chronic lung disease are. Lung ultrasonography (LUS) has emerged as a promising tool for assessing bronchiolitis severity and progression of the disease. The investigators will explore its use to improve diagnostic accuracy and treatment decisions, and develop AI-driven scoring tools for novel technology. Additionally, tidal breathing flow volume loops (TBFVL) offer a non-invasive method for evaluating airway obstruction in infants, with the potential to assess severity of bronchiolitis, treatment efficacy and post-infection lung function. In this project the investigators will combine the use of these modern technologies to improve treatment and follow-up of infants with LRTIs. The main aim for this observational study is to assess the utility of lung ultrasonography (LUS) and tidal flow volume loops (TBFVL) in infant lower respiratory tract infections (LRTIs) for individual risk stratification in acute and chronic settings. This aims to refine the management of bronchiolitis, identifying high-risk patients for chronic lung disease to tailor treatment and follow-up protocols. The project has three secondary objectives. 1. To assess correlation between LUS and TBFVL findings with clinical score at admission, length of stay, need of respiratory support and ICU admissions. 2. To assess duration of symptoms following acute bronchiolitis and evaluate the use of LUS and TBFVL in objectively examine post-infectious sequela. 3. To evaluate the long-term impact of bronchiolitis on lung function through clinical follow-up after a 12 month period. Lower respiratory tract infections (LRTIs) stand as the leading cause of hospitalization, while asthma is the leading cause of chronic lung disease among children in Nordic countries. The project seeks to improve risk stratification and treatment protocols in both acute and chronic settings. In the acute setting, the project endeavors to prognosticate individual patient outcomes, thereby individualize treatment and mitigating unnecessary hospital admissions, use of respiratory support and antibiotic administration. Additionally there is potential of more aggressive treatment to selected patients. The study aims to improve the understanding of pathophysiological processes of LRTIs in infants, providing objective metrics to evaluate disease severity and individualize treatment. The investigators aim to validate the utility, validity, and simplicity of handheld ultrasound devices as bedside diagnostic tools for this common disease, alongside affirming the value of tidal flow volume loops (TBFVL) in acute and chronic settings to assess airway obstruction in infants. Combining these modern technologies, evaluating affliction of both the parenchyme and the airways will probide a new perspective in treatment of LRTIs. In addition the project will strive to develop novel technology with AI-driven scoring tools of LUS. Furthermore, the project aims to examine the trajectory of symptoms post-LRTI and facilitate the early identification of patients with high-risk of chronic lung disease. Early detection of asthma and other chronic lung diseases holds the potential to improve outcomes and mitigate the need for hospitalization, thus easing both economic and emotional burdens associated with the disease. For caregivers, the lack of information concerning symptom duration and risk of future disease represents a significant knowledge gap. The project aims to address this, by examining post-infection symptom duration and identifying high-risk cohorts predisposed to chronic lung disease. This has the potential to both improve information, personalize follow-up and reduce hospital readmissions.

Azithromycin for Critical Asthma - Pediatrics

The CR-AZI Study will assess the immunomodulatory effects of Azithromycin for pediatric Critical Asthma.

Social Needs Screening and Chronic Diseases Study (WE CARE)

The goal of this clinical trial is to learn if the implementation of the WE CARE social determinants of health (SDOH) screening and referral intervention with an antiracist lens in primary care settings can lead to a meaningful decrease in chronic disease by monitoring conditions such as hypertension, diabetes, depression, hyperlipidemia, and asthma through clinical measures. The main question it aims to answer is: Does the WE CARE SDOH screening and referral intervention applying an antiracism lens informed implementation strategies have the potential to reduce racial/ethnic health inequities in chronic diseases for minoritized patients?

AeviceMD for Detection of Wheeze in Pediatric and Adult Populations

Respiratory signs and symptoms consisting of wheeze, cough, and breathlessness are obtained in a manual fashion through history taking and physical examination by the healthcare professional. Auscultation of the lung assesses airflow through the trachea-bronchial tree and is helpful in diagnosing various respiratory disorders. AeviceMD is a wearable device that can acquire and process lung sounds, thus assisting in the detection of abnormal lung sounds. The primary objective of this study is to determine if AeviceMD can detect wheeze of pediatrics and adults as accurately as a physician through auscultation. The secondary objective is to investigate if AeviceMD can be used for remote auscultation of breath sounds.

Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

This is a single-center, randomized, SHAM-controlled, parallel assignment, double-masked,8-week interventional study among children aged 8-17 years (not yet 18 years old) of age with obesity and asthma. (n=60), recruited from Duke Health Center Creekstone, to test the effectiveness of inspiratory muscle rehabilitation (IMR) as an acceptable add-on intervention to reduce dyspnea (feeling short-of-breath or breathless) and to promote greater activity in children with obesity and asthma. Clinic to test the effectiveness of inspiratory muscle rehabilitation (IMR) as an acceptable add-on intervention to reduce dyspnea (feeling short-of-breath or breathless) and to promote greater activity in children with obesity

The Puerto Rico Asthma Integrated Response Program ("PR-AIR")

The purpose of this study is to adapt and deliver an evidence-based multi-level intervention to reduce asthma disparities, and that promote and improve population health in the high-burden communities of San Juan, Puerto Rico. The Puerto Rico-Asthma Integrated Response Program (PR-AIR) will be implemented and evaluated to address pediatric asthma disparities in San Juan, PR, an area of high asthma burden. This study unfolds in two phases: In Phase 1, the researchers will collaborate with community stakeholders to identify needs, barriers and facilitators of PR-AIR implementation. Phase 2 consists of an evaluation of low-intensity (virtual) and high-intensity (in-person) methods of PR-AIR implementation outcomes using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework and a mixed methods approach.

Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)

This is single-center cross-sectional mechanistic study in lean and obese children with moderate-severe asthma, followed by a randomized, SHAM-controlled trial of Inspiratory Training (IT). The primary outcome is to describe the contributions of inspiratory muscle dysfunction (IMD) and Small Airway Dysfunction (SAD) to obesity-related versus non-obesity-related asthma. The study will involve training (IT) for 8 weeks at three intensity levels (SHAM, low and high). Target dose: 150 inspirations three times weekly. The population includes 6 to 17-year-old children with moderate to severe asthma and with a body mass index qualifying as normal habitus (BMI 5th to 84th CDC percentile) or obese habitus (≥95th percentile BMI and less than 170% of the 95th CDC percentile). Participants will be involved for 10 weeks. The investigators will use analysis of covariance (ANCOVA) to estimate and test the difference in mean values of baseline measures between obese and non-obese cohorts. Covariates will include age, sex (male/female), race/ethnicity, baseline asthma severity (NAEPP step 2 vs ≥3), and atopy status

Towards Digital Management of Paediatric Asthma

This pilot study aims to explore whether a digital approach to managing childhood asthma using connected inhalers and video consultations triggered by alerts from these devices - could work as well as standard in-person care. The connected inhalers track when children use their daily prevention medication and their rescue medication for asthma symptoms. If a child misses several days of prevention medication or uses their rescue inhaler frequently, their doctor receives an alert and can schedule a video consultation to adjust their treatment. Fifty children aged 4-12 years with asthma will participate for 8 months, with half using this digital system and half receiving usual care. The study will measure whether this new approach is practical and acceptable to families and doctors, and will look at its effects on asthma control, quality of life, and healthcare use. The results will help design a larger study to fully test if this digital approach could improve asthma care for children.

The Airports, Air Quality, and Asthma (AAA) Study

For children with asthma, exposure to indoor air pollution increases the risk of a serious asthma exacerbation, which can be life-threatening. Interventions aimed at improving indoor air quality, including use of a portable air cleaner with a high-efficiency particulate air (HEPA) filter, can reduce this risk, but the effectiveness, feasibility and acceptability of HEPA air cleaners varies by setting. In collaboration with a community health worker (CHW) delivered asthma education program, the investigators are conducting a randomized clinical trial to evaluate the effectiveness of HEPA air cleaners to improve indoor air quality and child asthma health in South King County of Washington state, a vulnerable community impacted by air pollution from airports and highway traffic. Key features of the Airports, Air Quality and Asthma (AAA) design include integration of CHWs into study procedures, including CHWs recruited from community-based organizations, into multiple aspects of the trial protocol. The investigators aim to recruit up to N=60 children with asthma randomized into intervention and control groups in a 1:1 ratio, conduct baseline assessments of indoor air quality and airway health, and collect repeated assessments of air quality and airway health during the three-month intervention period and after the trial concludes. Study findings will inform future approaches to integrate HEPA air cleaners into existing CHW asthma education programs in this and similar communities.

AeviceMD for Pediatric Asthma Management

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.

Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients

The goal of this research study is to test how good an app is in making asthma easier to manage for 372 adolescents/young adults. The app is a mobile version of the asthma action plan.

Cohort Multiple Randomized Controlled Trial in Pediatric Asthma

The overarching goal of this study is to optimize pediatric asthma care and to continuously evaluate variations/innovations of the care (including transformation to remote eHealth care). Primary Objectives within cmRCT cohort: * Provide a framework for multiple randomized (eHealth) interventions for asthmatic children * Generate short- and long-term data on Quality of life (QoL), asthma outcomes (asthma control, lung function), quality of care, self-management capacity, healthcare use, and therapy compliance in a representative secondary care pediatric asthma cohort. Secondary Objectives within cmRCT cohort: * Evaluate current pediatric asthma care at the Pediatric department of Medisch Spectrum Twente, in order to explore possible improvements for the pediatric asthma care. * Compare the short and long-term asthma outcomes between the eHealth care path and the outpatient care path. * Compose patient risk profiles that include both personal, clinical and exposome markers and clinical asthma endpoints (for example clinical admission/exacerbations).

The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life

This prospective observational study aims to assess the health-related quality of life (HRQoL) of 200 children (ages 5-16) with bronchial asthma, allergic rhinitis, or both, and their 200 parents, comparing 100 children receiving specific immunotherapy with 100 receiving routine treatment. Using EQ-5D-Y(EuroQol five dimensions questionnaire, youth version), disease-specific scales, and newly developed Chinese versions of EQ-5D-Y and EQ-HWB-S (EuroQol health and well-being questionnaire, short version), the study evaluates HRQoL changes over 1 and 2 years and explores the impact on caregiver burden and spillover effects. A control group of 100 healthy children and their parents will be included. Data collection involves baseline and follow-up surveys, clinical data from medical records, and statistical analyses to compare treatment effects and validate measurement tools.