Bronchiolitis

26

Review clinical trials related to Bronchiolitis. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

The LalelaLung Study: Digital Stethoscope Clinical Evaluation

Pneumonia is the leading infectious cause of death in children under five years of age worldwide, and most of these deaths occur in low- and middle-income countries. In these settings, frontline health workers diagnose pneumonia using the World Health Organization's Integrated Management of Childhood Illness (IMCI) guidelines, which rely mainly on counting how fast a child is breathing and checking for chest indrawing. This approach has saved many lives, but it is not very specific. As a result, many children who actually have self-limiting viral illnesses that do not require antibiotics are nonetheless treated with antibiotics, contributing to the global rise of antimicrobial resistance. New digital stethoscopes paired with artificial intelligence (AI) can record a child's lung sounds and automatically detect abnormal sounds such as crackles and wheezes with accuracy comparable to physicians. The LaLeLa Lung Study will evaluate whether adding an AI-enabled digital stethoscope to standard IMCI assessment improves the accuracy of pneumonia diagnosis among children aged 2 to 59 months who present with cough and/or difficult breathing at a primary care clinic in Cape Town, South Africa. The main component (Objective 1) is a randomized, triple-blinded diagnostic accuracy study that will enroll 350 children, randomly assigned in a 1:1 ratio to either IMCI care enhanced by the AI-enabled digital stethoscope or standard IMCI care. An independent panel of physicians, blinded to the AI results and to study-arm assignment, will review each case and serve as the reference standard for determining whether pneumonia was truly present. The investigators hypothesize that IMCI enhanced by the AI stethoscope will diagnose pneumonia more accurately, and target antibiotics more appropriately, than standard IMCI alone. Nested sub-studies will additionally evaluate a second AI stethoscope for tuberculosis detection, a wearable lung-sound and respiratory-rate patch, an automated respiratory-rate monitor, and a smartphone-connected pulse oximeter. A separate component (Objective 2) is a mixed-methods implementation study at a second clinic that will assess how easily health workers can use these devices, how acceptable the devices are to health workers and caregivers, and how well the devices fit into routine clinic workflows. Throughout the study, all AI-generated results will remain concealed from clinic staff, study clinicians, and caregivers, so the AI-generated results will not influence the care any child receives. All children continue to receive standard IMCI care. Findings will help inform whether AI-enabled digital auscultation should be integrated into childhood pneumonia care in South Africa and similar low-resource settings, with the goal of improving diagnosis, strengthening antibiotic stewardship, and reducing antimicrobial resistance and child mortality.

Participants needed: 350
Trial details
Phase: Phase 4Age: 2-59Biological sex: AllType: InterventionalSponsor: Johns Hopkins UniversityUpdated: Jul 13, 2026
Eligibility criteria

Age 2 to 59 months at the time of screening [+4]

Presence of WHO-defined emergency signs requiring immediate referral or hospital... [+4]

Status: Not yet recruiting

The LalelaLung Study: Digital Stethoscope Clinical Evaluation

Pneumonia is the leading infectious cause of death in children under five years of age worldwide, and most of these deaths occur in low- and middle-income countries. In these settings, frontline health workers diagnose pneumonia using the World Health Organization's Integrated Management of Childhood Illness (IMCI) guidelines, which rely mainly on counting how fast a child is breathing and checking for chest indrawing. This approach has saved many lives, but it is not very specific. As a result, many children who actually have self-limiting viral illnesses that do not require antibiotics are nonetheless treated with antibiotics, contributing to the global rise of antimicrobial resistance. New digital stethoscopes paired with artificial intelligence (AI) can record a child's lung sounds and automatically detect abnormal sounds such as crackles and wheezes with accuracy comparable to physicians. The LaLeLa Lung Study will evaluate whether adding an AI-enabled digital stethoscope to standard IMCI assessment improves the accuracy of pneumonia diagnosis among children aged 2 to 59 months who present with cough and/or difficult breathing at a primary care clinic in Cape Town, South Africa. The main component (Objective 1) is a randomized, triple-blinded diagnostic accuracy study that will enroll 350 children, randomly assigned in a 1:1 ratio to either IMCI care enhanced by the AI-enabled digital stethoscope or standard IMCI care. An independent panel of physicians, blinded to the AI results and to study-arm assignment, will review each case and serve as the reference standard for determining whether pneumonia was truly present. The investigators hypothesize that IMCI enhanced by the AI stethoscope will diagnose pneumonia more accurately, and target antibiotics more appropriately, than standard IMCI alone. Nested sub-studies will additionally evaluate a second AI stethoscope for tuberculosis detection, a wearable lung-sound and respiratory-rate patch, an automated respiratory-rate monitor, and a smartphone-connected pulse oximeter. A separate component (Objective 2) is a mixed-methods implementation study at a second clinic that will assess how easily health workers can use these devices, how acceptable the devices are to health workers and caregivers, and how well the devices fit into routine clinic workflows. Throughout the study, all AI-generated results will remain concealed from clinic staff, study clinicians, and caregivers, so the AI-generated results will not influence the care any child receives. All children continue to receive standard IMCI care. Findings will help inform whether AI-enabled digital auscultation should be integrated into childhood pneumonia care in South Africa and similar low-resource settings, with the goal of improving diagnosis, strengthening antibiotic stewardship, and reducing antimicrobial resistance and child mortality.

Participants needed: 350
Trial details
Phase: Phase 4Age: 2-59Biological sex: AllType: InterventionalSponsor: Johns Hopkins UniversityUpdated: Jun 9, 2026
Eligibility criteria

Age 2 to 59 months at the time of screening [+4]

Presence of WHO-defined emergency signs requiring immediate referral or hospital... [+4]

Status: Recruiting

Evaluation of the Impact of EHR-Alerts on Clinical Decision Support Pathway Use in Bronchiolitis, and the Impact of Pathway Use on the Prescription of High Flow Nasal Cannula and Other Elements of High Value Care.

The goal of this experimental study is to learn whether different types of Electronic Health Record (EHR) alerts that direct clinicians to reference clinical guidelines embedded in the increase the use of these guidelines and the delivery of evidence-based care in children presenting to the hospital with bronchiolitis. The main questions it aims to answer are: * Do EHR-alerts increase clinicians' us of evidence-based EHR-integrated Clinical Decision Support (CDS) guidelines for the care of bronchiolitis and * Is the use of EHR-integrated CDS-guidelines for the care of bronchiolitis associated with deceases in low-value use of High Flow Nasal Cannula (HFNC) and improvement in other aspects of high-value care for this disease Patients will be randomized on the encounter-level to have the patient's treating providers receive no EHR-alert or one of two types of EHR-alert (non-interruptive or interruptive) reminding the provider that the EHR-integrated CDS guideline is available for the care or bronchiolitis. Researchers will compare the rate of use of EHR-integrated CDS guidelines in patients whose clinicians did not receive any EHR-alerts, to those whose clinicians received a non-interruptive alert and to those whose clinicians received an interruptive Best Practice Advisory (BPA). In addition, the study will evaluate whether the utilization of the EHR-integrated CDS guideline in a given encounter was associated with less low-value HFNC use, and differences in other elements of low-value care for bronchiolitis. Patients in all groups will continue to receive standard hospital care for bronchiolitis as determined by the patient's treating clinicians.

Participants needed: 8,000
Trial details
Age: Up to 24Biological sex: AllType: InterventionalSponsor: Johns Hopkins UniversityUpdated: May 29, 2026Locations: 3
Eligibility criteria

Children <=24 months of age presenting to the emergency room and/or hospitalized...

Current encounter is birth-encounter [+2]

Status: Recruiting

Characterization of Bronchodilator Response in Children With Bronchiolitis Using Phenotypic and Genotypic Features

Bronchiolitis is the leading cause of pediatric morbidity and healthcare costs. Despite the commonplace use of bronchodilator treatments, like albuterol, in conditions like asthma, their efficacy in bronchiolitis remains controversial due to the heterogeneity in patient response. Although studies indicate that bronchodilators do not enhance outcomes in bronchiolitis, meta-analyses can obscure the heterogeneity of treatment effects. While bronchodilator response genetics have not been explored in bronchiolitis, treatment effectiveness variations often depend on genomic factors. Genome-wide association studies (GWAS) have linked genetic variants with bronchodilator response and outcomes in childhood asthma, suggesting a bronchodilator-responsive genotype. This proposal aims to extend this paradigm to bronchiolitis, addressing the gap in knowledge where GWAS and clinical characteristics intersect. The proposed study's objective is to characterize phenotypic and genotypic variations of children with bronchiolitis and their association with bronchodilator response. We hypothesize that children with bronchiolitis who exhibit clinical and historical characteristics associated with atopy and specific physical findings have genetic variants linked to bronchodilator response. To achieve this, we propose to (Aim 1) define airway responsiveness to bronchodilator treatment in children with bronchiolitis using the change in respiratory score, (Aim 2a) identify the associations between candidate genetic variants and bronchodilator response among children with bronchiolitis, and (Aim 2b) determine the associations between candidate genetic variants and clinical patient data to identify bronchodilator-responsive children with bronchiolitis. A prospective, double-blind, randomized, placebo-controlled trial of a single albuterol dose in children aged 3 to 24 months presenting with bronchiolitis to the emergency department will be conducted to achieve these aims. Patient information and respiratory assessment outcomes will be collected before and after intervention. Blood, urine, DNA buccal swabs, and nasopharyngeal swabs will also be collected. Completion of these aims will result in a novel clinical prediction model for bronchodilator response determination in bronchiolitis, integrating clinical, physical, and genetic data. Furthermore, this research supports the candidates' career development goals of advancing training in clinical trial research design and execution and becoming an expert in clinical and translational methods to enhance pediatric emergency department health and outcomes. Ultimately, this work will inform an R01 application to validate an evidence-based prediction rule for identifying bronchodilator-responsive children with bronchiolitis through a multi-center emergency medicine research network, optimizing therapeutic approaches, and reducing resource use in those with a low likelihood of bronchodilator response.

Participants needed: 400
Trial details
Phase: Phase 3Age: 3-24Biological sex: AllType: InterventionalSponsor: Nemours Children's ClinicUpdated: May 8, 2026Locations: 1
Eligibility criteria

Children between 3 to 24 months of age [+3]

Patients previously enrolled in the PI's K12 study [+5]

Status: Recruiting

Descriptive Study of the Initial Management of Young Children With Moderate Acute BRONCHiotitis With Home Hospitalisation

The occurrence of a first episode of acute bronchiolitis in an infant or young child (3 months-2 years) always represents a medical event that generates stress for parents and in some cases for the primary care physician when it is necessary to decide on the child's orientation for treatment. Each year, during the winter season, this pathology affects 30% of infants under two years old (480,000 annual cases in France), generates approximately 30,000 hospitalizations and exposes to an overall mortality risk of 0.08%. According to the recommendations of the HAS (2019), moderate bronchiolitis does not require systematic hospitalization and can be managed in a Home Hospitalization (HAD) context. When the child's examination data do not find signs of severity, the SpO2 measurement is greater than 92% and the family context allows for return home, HAD management is a reasonable option and represents an alternative to the classic scheme of assessing the level of severity by the emergency department and subsequent hospitalization if necessary. HAD management is carried out within the framework of a very structured "patient pathway", codified and supervised by the pediatric teams and doctors of this department. This patient pathway concerns children with a moderate form of bronchiolitis without oxygen requirements at the time of inclusion. This must be 48 hours from the onset of the child's respiratory clinical signs. The main objective of this study is to describe the need for oxygen therapy for a young child with moderate acute bronchiolitis syndrome during home hospitalization (HAD) care.

Participants needed: 40
Trial details
Age: 2-2Biological sex: AllType: ObservationalSponsor: ElsanUpdated: Apr 21, 2026Locations: 1
Eligibility criteria

Any infant with moderate bronchiolitis according to the HAS definition (except f... [+6]

Patient not receiving health protection [+6]

Status: Recruiting

Deployment-Related Lung Disease Research Database and Biorepository

The purpose of this research study is to establish a research database and biorepository for patients at National Jewish Health (NJH) who served in Operation Iraqi Freedom (OIF) or Operation Enduring Freedom (OEF). This study will also include civilian contractors who worked as part of these military operations in Iraq or Afghanistan. The biorepository would store blood samples obtained from these patients during a clinic visit. The research database would store prospectively and retrospectively collected clinical and exposure data that would enable us to comprehensively characterize each case.

Participants needed: 500
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: National Jewish HealthUpdated: Apr 15, 2026Locations: 1Duration: 1 Day
Eligibility criteria

Served in the southwest Asia wars

Did not served in the southwest Asia wars

Status: Not yet recruiting

Risk Factors and Severity of Bronchiolitis in Hospitalized Children at Assiut University Hospital

The purpose of this observational study is to identify the risk factors that make bronchiolitis more severe in infants and toddlers. Bronchiolitis is a common viral lung infection that causes inflammation and airway obstruction, often leading to breathing difficulties and hospitalization in young children. Researchers will observe approximately 65 children, aged 1 to 24 months, who are admitted to Assiut University Hospital for acute bronchiolitis. Because this is an observational study, participants will receive standard medical care, and no experimental treatments will be tested. During the hospital stay, researchers will collect information through parent questionnaires and standard medical records. The research team will gather data on: * Family, social, and environmental factors, such as infant feeding practices, premature birth, and exposure to passive smoking. * The child's clinical symptoms and overall severity of illness upon arrival at the hospital. * Routine test results and the types of supportive care the child needs, such as extra oxygen or feeding assistance. * The total length of the hospital stay and whether the child requires intensive care (ICU) admission. By identifying which factors are most closely linked to severe illness, the study aims to help doctors better predict the course of the disease early on, evaluate adherence to treatment guidelines, and ultimately reduce the health burden of bronchiolitis.

Participants needed: 65
Trial details
Age: 1-24Biological sex: AllType: ObservationalSponsor: Assiut UniversityUpdated: Apr 1, 2026
Eligibility criteria

Children aged 1-24 months presenting with acute bronchiolitis, defined per AAP 2... [+1]

Known congenital heart disease, chronic lung disease (e.g., bronchopulmonary dys... [+3]

Status: Not yet recruiting

National Observatory of Children Hospitalized With Bronchiolitis

OVNI3 is multicenter, non-interventional study based on the analysis of retrospective patient data extracted from medical records and collected as part of routine clinical care following hospitalization for bronchiolitis

Participants needed: 1,000
Trial details
Age: 1-12Biological sex: AllType: ObservationalSponsor: Association Clinique Thérapeutique Infantile du val de MarneUpdated: Mar 20, 2026Locations: 1
Eligibility criteria

Children under 12 months [+6]

Refusal to participate by the legal representative [+1]

Status: Not yet recruiting

Gut Microbiome and Immune Response in Severe RSV Infection in Vietnamese Infants

Respiratory syncytial virus (RSV) is a leading cause of severe lower respiratory tract infection in young children, and a substantial proportion of severe cases occur in previously healthy infants. The gut-lung axis suggests that gut microbiome composition may modulate respiratory immune responses. This prospective observational study in Vietnam will compare gut microbiome profiles and systemic immune cytokine responses between infants with severe RSV infection and those with mild RSV infection, aiming to identify microbiome-immune signatures associated with disease severity.

Participants needed: 250
Trial details
Age: 1-24Biological sex: AllType: ObservationalSponsor: Phuc Huu PhanUpdated: Feb 18, 2026Locations: 1
Eligibility criteria

Not listed

Status: Not yet recruiting

PremaBiom: Metatranscriptomics of the Respiratory Microbiome to Predict the Occurrence of Bronchopulmonary Dysplasia in Preterm Infants

The goal of this clinical trial is to understand the impact of respiratory microbiome maturation in respiratory health of preterm infants under 32 gestational weeks. The main questions it aims to answer are: * What is the role of microbiome maturation in respiratory health (development of bronchopulmonary dysplasia, childhood asthma and viral respiratory infections) of preterm infants ? * Which environmental or health factors are involved in the maturation of the respiratory microbiome ? Participants will undergo follow-up from birth until 3 years of corrected age including nasal swabs, stool samples, and for some of them blood and milk sample.

Participants needed: 270
Trial details
Age: Up to 72Biological sex: AllType: InterventionalSponsor: University Hospital, CaenUpdated: Feb 13, 2026Locations: 6
Eligibility criteria

Preterm infants with gestational age at birth lower than 32 gestational weeks an... [+3]

Palliative care only [+3]

Status: Recruiting

Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms

The purpose of this post-market clinical investigation is to assess in a real-life setting, the effectiveness, usage, tolerance, safety and satisfaction of 4 isotonic and hypertonic seawater-based CE-marked nasal sprays. The main questions it aims to answer are: * Efficacy, * Safety, * Usage, * Satisfaction, in real-life usage among infants, children, adults and pregnant or breastfeeding women suffering from acute and chronic sinonasal pathologies. The 4 medical devices under investigation will be used in accordance with their intended use, target populations and medical indications.

Participants needed: 1,065
Trial details
Age: 15+Biological sex: AllType: InterventionalSponsor: Laboratoire de la MerUpdated: Dec 3, 2025Locations: 32
Eligibility criteria

Subject's age and medical condition in compliance with the intended use and popu... [+24]

Status: Recruiting

Non-Invasive Ventilation Versus Neurally-Adjusted Ventilatory Assistance (NAVA) for the Treatment of Bronchiolitis

This project aims to answer whether the use of a Neurally-Adjusted Ventilatory Assistance mode for non-invasive ventilation in pediatric patients with bronchiolitis results in improved comfort and reduced escalations in therapy (including intubation) when compared to using a standard mode of non-invasive ventilation. Neurally-Adjusted Ventilatory Assistance (NAVA) has been shown to result in greater synchrony then the standard mode of non-invasive ventilation. The study team hypothesizes that this improved synchrony can result in important clinical improvements when NAVA is used to treat children with bronchiolitis.

Participants needed: 130
Trial details
Age: 0-2Biological sex: AllType: InterventionalSponsor: Montefiore Medical CenterUpdated: Sep 5, 2025Locations: 1
Eligibility criteria

Patients under the age of two years old with a diagnosis of bronchiolitis presen... [+1]

Patients unable to utilize a nasogastric tube [+4]

Status: Recruiting

Low-value Care, and Variation in Practice for Children Hospitalized With Bronchiolitis

Low-value care is defined as the use of a health service, such as diagnostics and treatments, for which the harms or costs outweigh the benefits. In pediatrics, investigations or treatments can be unpleasant or traumatizing to the child, can prolong the time spent in hospital, and can create a cascade of further futile investigations and treatments. Several of the commonly used diagnostics and treatments in bronchiolitis are considered low-value, making it a great model to study low-value care in pediatrics. The purpose of CareBEST is to study the use of 6 low-value healthcare services in children aged 1 to 12 months hospitalized with bronchiolitis, their costs, and measure the variability in practice of these services. The main questions this study aims to answer are: 1. How frequently are 6 low-value care health services used in children hospitalized with bronchiolitis? These 6 low-value care health services are: 1) respiratory virus testing; 2) chest x-rays; 3) continuous pulse oximetry; 4) short-acting beta-agonists; 5) systemic corticosteroids; and 6) antibiotics. * Are there factors that predict the use of these services? * What are the costs of the use of these services? 2. How much variability is there between different patients, different doctors, and between hospitals in the use of these 6 low-value health services ? 3. Are differences in use of low-value health services associated with patient and family characteristics (like race and ethnicity, socioeconomic status, language), and do these contribute to disparities in care? Participants will have their infant's medical chart reviewed during their hospitalization. They will also have 2 short questionnaires to complete, once during their child's admission to the hospital, and one 30 days later to ask about whether their child required any additional medical care. They will additionally be asked to complete a questionnaire on their perceptions regarding their child's care while hospitalized, including the use of shared-decision making and their understanding of and involvement in the care decisions made. This analysis will provide a better understanding of treatment of bronchiolitis in Canada and help in the development of effective interventions to reduce low-value care.

Participants needed: 3,000
Trial details
Age: 28-12Biological sex: AllType: ObservationalSponsor: St. Justine's HospitalUpdated: Jul 23, 2025Locations: 15
Eligibility criteria

Children aged >28 days to <12 months [+1]

Status: Recruiting

Respiratory Support and Treatment for Efficient and Cost-Effective Care

This project aims to answer the essential questions about the management of acute, pediatric respiratory illness, accelerate recovery from these all-too-common diseases, curb unnecessary costs of care, and demonstrate UPMC Children's Hospital of Pittsburgh's capabilities as the premier, world-class leader in the arena of pediatric learning healthcare systems. REST EEC will focus on the question of whether clinical decision support (CDS) facilitates the standardization of the initiation and weaning of heated high flow nasal cannula (HHFNC) for bronchiolitis.REST EEC will focus on whether the application of CDS improves adherence to a standardized guideline and leads to improved patient-centered outcomes.

Participants needed: 198
Trial details
Age: Up to 2Biological sex: AllType: InterventionalSponsor: Christopher HorvatUpdated: Jul 11, 2025Locations: 1
Eligibility criteria

<2 years of age Bronchiolitis WOB Score >2

Immunocompromised [+3]

Status: Not yet recruiting

Assessing the Burden of Respiratory Syncytial Virus (RSV)

This study examines the impact of Respiratory Syncytial Virus (RSV) on people of all ages, from infants to the elderly. It uses hospital records collected between January 2018 and December 2024 to understand: * How often does RSV occur * Who is most at risk * The long-term and financial effects of RSV

Participants needed: 1,500
Trial details
Biological sex: AllType: ObservationalSponsor: Abu Dhabi Health Services CompanyUpdated: Jun 19, 2025Locations: 1
Eligibility criteria

Patients of all ages with a confirmed diagnosis of RSV infection [+2]

Patients with suspected RSV infection that is not laboratory-confirmed [+1]

Status: Not yet recruiting

Study of Pneumococcal Carriage in RSV Bronchiolitis in Infants Aged 6 to 18 Months

The relationship between RSV (human respiratory syncytial virus) infections and invasive infections or pneumonia caused by Streptococcus pneumoniae has been observed epidemiologically for several years. Few fundamental data exist to support the epidemiological relationship. This study will investigate the proportion of pneumococcal carriage in RSV-infected infants and noninfected infants (proportion, serotype profile).

Participants needed: 120
Trial details
Age: 6-18Biological sex: AllType: ObservationalSponsor: Assistance Publique - Hôpitaux de ParisUpdated: May 15, 2025Locations: 1
Eligibility criteria

Infants aged 6 months to 18 months inclusive [+5]

Chronic respiratory illness [+3]

Status: Recruiting

Efficacy of Lavender Essential Oil Chest Wraps in Infants With Bronchiolitis

The goal of this clinical trial is to learn if lavender essential oil chest wraps relieve cough in infants with bronchiolitis compared to standard care. Furthermore, the researchers will evaluate if breathing difficulties, nighttime awakening and impact on parents will be improved by the lavender oil chest wraps. Infants will be randomized to receive standard care with the addition of lavender oil chest wraps or to receive standard care alone. The study will take place in two locations in Switzerland, at the Geneva University Hospital and the Fribourg Cantonal Hospital.

Participants needed: 400
Trial details
Phase: Phase 4Age: Up to 11Biological sex: AllType: InterventionalSponsor: University Hospital, GenevaUpdated: Mar 30, 2025Locations: 2
Eligibility criteria

Bronchiolitis: clinical diagnosis based on the combination of respiratory distre... [+2]

Patients with underlying diseases that impact respiratory or heart function (con... [+6]

Status: Recruiting

Effect of Chest Physiotherapy on Clinical Outcome of Infants With Bronchiolitis

The goal of clinical trial study is to evaluate effect of chest physiotherapy educational on mother's knowledge, practice and clinical outcomes of infants aged less than 12 months diagnosed with bronchiolitis by physician The main questions aims to answer: * Does chest physiotherapy improve clinical outcomes of infants with bronchiolitis? * Does educational program improve mothers knowledge and practice regarding chest physiotherapy? Researcher compare two groups one receive routine hospital care (control group) other receive chest physiotherapy applied by mothers in addition to routine hospital care and will be followed up for 3 days

Participants needed: 40
Trial details
Age: 1-1Biological sex: AllType: InterventionalSponsor: Hawler Medical UniversityUpdated: Mar 6, 2025Locations: 1
Eligibility criteria

1. Mothers of infants diagnosed with bronchiolitis. 2. Presence of crackle on au...

Children with contraindication of chest physiotherapy (ex. Fracture, recent surg... [+1]

Status: Recruiting

Association of Dysbiosis and Immune Response in Bronchiolitis in Under 12 Months -Old Infants

Acute bronchiolitis is a common disease in children under the age of two, caused mainly by the respiratory syncytial virus (RSV). Furthermore, given the same medical history, it is still very difficult to predict the course and severity of the infection at the onset of symptoms, Some studies have highlighted the importance of the microbiota (intestinal, oral or nasopharyngeal) and of the immune response to RSV in children, We will include 80 children under 2 years old with hospitalized bronchiolitis and non-hospitalized bronchiolitis. Oral, nasal and stool samples will be taken to study the various microbiota in search of dysbiosis. A capillary blood sample will be taken for immune studies.

Participants needed: 120
Trial details
Age: 1-12Biological sex: AllType: ObservationalSponsor: Assistance Publique - Hôpitaux de ParisUpdated: Feb 26, 2025Locations: 3
Eligibility criteria

Infants <12 months [+4]

Chronic respiratory illness [+3]

Status: Recruiting

Peginterferon α-2b Injection for the Treatment of Pediatric RSV Bronchiolitis

This is a multicenter, randomized, positive-controlled, non-inferiority clinical study, planning to enroll 90 children with bronchiolitis caused by respiratory syncytial virus infection, to evaluate the safety and efficacy of inhaled Peginterferon α-2b injection compared to recombinant human interferon α2b in the treatment of pediatric respiratory syncytial virus bronchiolitis.

Participants needed: 90
Trial details
Age: 6-2Biological sex: AllType: InterventionalSponsor: Children's Hospital of Soochow UniversityUpdated: Feb 14, 2025Locations: 3
Eligibility criteria

The guardian of the child is able to understand the content, requirements, and l... [+6]

Extreme restlessness, drowsiness, coma, and possibly requiring mechanical ventil... [+7]

Status: Not yet recruiting

Utility of Severity Scales in Clinical Practice in Children Hospitalized Due to Bronchiolitis.

Prospective observational study of patients hospitalized with bronchiolitis. The objective of our study is to compare the accuracy of commonly used clinical scales for bronchiolitis to predict relevant outcomes.

Participants needed: 150
Trial details
Age: 5-24Biological sex: AllType: ObservationalSponsor: Szpital im. Św. Jadwigi ŚląskiejUpdated: Dec 17, 2024Locations: 1
Eligibility criteria

Tachypnoea (WHO definition). [+6]

Status: Not yet recruiting

Comparison of 3% Hypertonic Saline and Salbutamol in Children With Bronchiolitis

Bronchiolitis is a common lower respiratory tract infection that often leads to hospitalization in infants. The use of nebulized 3% hypertonic saline for treating bronchiolitis is being explored as an alternative to Salbutamol. In nebulizers, normal saline serves as a diluent, allowing water molecules or drugs to be inhaled into the lungs. However, there has been limited research on this topic, and no local trials have been conducted. This study aims to compare the effectiveness of 3% hypertonic saline and Salbutamol in treating bronchiolitis. A randomized controlled trial will be conducted at the Department of Pediatric Medicine, Services Institute of Medical Sciences, Lahore, over one year, involving 100 infants divided into two groups: one receiving 3% hypertonic saline and the other receiving Salbutamol. The RDAI score will be evaluated before and during treatment to assess recovery time. Data will be collected using a proforma and analyzed with SPSS v25. The study aims to determine which treatment leads to faster symptom control and shorter hospital stays, with significance defined as a p-value ≤0.05. The findings will guide future treatment choices for infants with bronchiolitis.

Participants needed: 100
Trial details
Age: 2-24Biological sex: AllType: InterventionalSponsor: University of Health Sciences LahoreUpdated: Oct 30, 2024
Eligibility criteria

Infants aged 2-24 months [+2]

Congenital heart disease [+1]

Status: Not yet recruiting

Artificial Intelligence-based Voice Assessment of Children and Adults Respiratory Conditions

Acute and Chronic respiratory conditions represent a leading cause of death and morbidity in children and adults worldwide. The diagnosis of bronchiolitis and asthmatic exacerbations is based on clinical, and mostly subjective, clinical parameters with moderately accurate prognostic role. Patients undergoing neck radiotherapy need invasive assessments of larynx. A simple biomarker like Voice may facilitate the management of these conditions. Recent studies showed that VOICE may be used as a good and easy biomarker to diagnose and monitor several respiratory and non-respiratory conditions. A prospective study aimed to collected VOICE and other clinical data in adults and children with common acute and chronic respiratory conditions at high impact on healthcare systems will be performed. VOICE-omic data will be linked with clinical findings generating data integration, using artificial intelligence technology to develop a Decision Support Systems to provide the basis for non-invasive personalised early recognition, diagnosis, monitoring and prognosis of patients with these conditions.

Participants needed: 200
Trial details
Age: 12-70Biological sex: AllType: InterventionalSponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCSUpdated: Oct 18, 2024Locations: 2
Eligibility criteria

Children with bronchiolitis <24 months of age clinically characterized according... [+3]

Children with comorbidities including genetic disorders; [+8]

Status: Recruiting

Pediatric and Ambulatory Research in Infectious Diseases

Many ambulatory networks are mainly based on diagnoses made by first-line physicians not specifically trained to join the network. Here we aim to set up a surveillance network on pediatric infectious diseases with an investment in teaching with specific trainings of participating pediatricians, increasing in use of point of care tests, and automated data extraction from the computers of the pediatricians.

Participants needed: 400,000
Trial details
Age: 1-16Biological sex: AllType: ObservationalSponsor: Association Clinique Thérapeutique Infantile du val de MarneUpdated: Feb 8, 2024Locations: 1Duration: 5 Years
Eligibility criteria

pharyngitis [+9]

parental refusal

Status: Not yet recruiting

Outcomes of Children After Hospitalization in Intensive Care Unit

More than 10,000 children are hospitalized in an PICU every year in Canada. While most of them will survive their PICU hospitalization and their critical illness, some children will not recover to their pre-illness level. Some may develop behavioral, physical, emotional or developmental problems and difficulties at school. All these problems are elements that are part of the Pediatric Post-Intensive Care Syndrome (PICS-p). It is important to understand the elements (risk factors) that play a role in the development of PICS-p. In Canada, there is no systematic follow-up for children after they leave the PICU. Understanding what can cause PICS-p (risk factors) and how much PICS-p has an impact on children and their family is very important to the family well-being.

Participants needed: 690
Trial details
Age: Up to 18Biological sex: AllType: ObservationalSponsor: St. Justine's HospitalUpdated: Nov 9, 2023Locations: 8
Eligibility criteria

Children ≤18yo hospitalized in PICU for ≥96 hours

gestational age <37 weeks or age >18 years at PICU entry; [+2]