Clinical Research Directory

Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments

Bronchiolitis is a common viral infection of the small airways that affects infants, particularly during respiratory syncytial virus epidemics. Some infants mainly develop feeding difficulties, with a marked reduction in milk intake or refusal to feed, while showing no immediate signs of severe respiratory impairment. These infants often need nutritional support through a nasogastric tube, which is a small tube passed through the nose into the stomach. Under usual care, starting enteral nutrition generally requires admission to a pediatric short-stay unit or a conventional inpatient ward. The purpose of this study is to determine whether a short period of enteral nutrition provided directly in the pediatric emergency department can reduce the total number of days spent in hospital during the 14 days following inclusion, compared with usual inpatient care. The short-term pathway is called the Short-Term Enteral Nutrition Protocol in the Pediatric Emergency Room (STENP-PER). The study will include 448 infants treated in eight pediatric emergency departments in France. Eligible infants will be between 8 completed weeks of corrected age and 11 months and 30 days of chronological age. They must have bronchiolitis, have had respiratory symptoms for at least 72 hours, and require nutritional support because their feeding has fallen below half of the usual amount during the previous 12 hours or because they refuse to feed. Infants with signs of severe respiratory, neurological, or nutritional illness, important medical risk factors, or circumstances that would make discharge or follow-up unsafe will not be included. This is a cluster-randomized stepped-wedge study. This means that the pediatric emergency departments, rather than individual infants, will be randomly assigned to the order in which they introduce the STENP-PER pathway. All participating departments will initially provide usual inpatient care. They will then progressively switch to the new pathway over four annual respiratory syncytial virus epidemic seasons. Each department will therefore contribute information during both a usual-care period and an intervention period. During the usual-care period, infants will be admitted to a pediatric short-stay unit or conventional inpatient ward for enteral nutrition and clinical monitoring, according to the usual procedures of each hospital. During the STENP-PER period, trained emergency department staff will place a nasogastric tube and provide continuous enteral nutrition for six hours while monitoring the infant's general condition, breathing, vital signs, and any adverse events. A parent will remain with the infant whenever possible. Parents will receive practical education, including information and instruction on nasal clearance. After six hours, the infant will be reassessed by the clinical team. If the infant's condition allows it, the infant will return home. If hospital monitoring or treatment is still needed, the infant will be admitted according to usual care. Participation in the study will not prevent clinicians from changing or stopping the feeding procedure when this is considered necessary for the infant's safety. The infant's health and use of healthcare services will be followed from inclusion through Day 14. Information will be obtained from hospital records and through a telephone call with the parents around Day 14. The main outcome is the total number of days spent in hospital during this period. This includes an immediate hospital stay after the first emergency department visit and any later hospitalization or rehospitalization related to the same episode of bronchiolitis or its management. The study will also compare the percentage of infants admitted immediately, the percentage transferred to another hospital, parents' satisfaction and experience of care, parents' understanding of advice about bronchiolitis, healthcare professionals' satisfaction, and the number and type of adverse events. The investigators will also examine how well the pathway is introduced and followed in each emergency department, how acceptable it is to families and healthcare professionals, the barriers and factors supporting its use, and whether it can be maintained and transferred to other hospitals. Interviews with parents and group discussions with healthcare professionals will provide additional information about their experience. Finally, a health-economic evaluation will compare the costs of the two care strategies over 14 days. The study is expected to show whether providing short-term enteral nutrition in the pediatric emergency department is a safe and effective alternative to systematic hospital admission for carefully selected infants with bronchiolitis and predominant feeding difficulties.

Neutrophil Monocyte Lymphocyte Ratios in Pediatric Chest Infections

This prospective cohort study aims to evaluate neutrophil-to-lymphocyte ratio, monocyte-to-lymphocyte ratio, and neutrophil-to-monocyte ratio in children with lobar pneumonia, bronchiolitis, and bronchopneumonia compared with healthy children.

Comparison of Two Methods of Immunoprophylaxis Against RSV in Term Newborns

Bronchiolitis is a lower respiratory tract infection, extremely common in pediatrics, and potentially serious. Bronchiolitis affects nearly 30% of infants under 2 years old each year, representing approximately 480,000 cases annually worldwide. Each year, 2 to 3% of infants under 1 year old are hospitalized for bronchiolitis. The virus primarily found worldwide and in France is RSV. Given the scale, frequency, and potential severity of the illness, several immunoprophylaxis methods have been developed. Currently, there are two methods: the ABRYSVO vaccine, administered to pregnant women during the last month of pregnancy for immunization via the placenta through the transplacental passage of anti-RSV-A and RSV-B antibodies; or neonatal immunoprophylaxis with BEYFORTUS, which involves an intramuscular injection of the monoclonal antibody nirvesimab directly into the newborn immediately before discharge from the maternity ward during the epidemic period. Currently, no superiority or difference has been described for either immunoprophylaxis method.

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.

Nebulized 3% Hypertonic Saline Solution Treatment of Bronchiolitis in Infants

\- Determine the efficacy of nebulized salbutamol/hypertonic saline combination in moderate to severe bronchiolitis.

Optimising Antibiotic Use for Paediatric Lower Respiratory Tract Infections in Africa

Lower respiratory tract infections (LRTIs) remain a leading cause of hospitalisation and death among young children in Africa. Although viral infections account for a substantial proportion of LRTIs, antibiotics are frequently prescribed because distinguishing between viral and bacterial infections can be challenging. This contributes to unnecessary antibiotic exposure and the rising global public health challenge of antimicrobial resistance. This pragmatic, unblinded randomised controlled study will evaluate whether the combination of point-of-care (POC) C-reactive protein (CRP) testing and the PREPARE clinical severity score can safely reduce antibiotic use among children aged 2 to 24 months hospitalised with LRTI at Chris Hani Baragwanath Academic Hospital (CHBAH), South Africa. Participants will be randomly assigned in a 1:1 ratio to either the intervention group, where antibiotic decisions are guided by serial POC CRP measurements and repeated PREPARE severity assessments, or a control group receiving routine clinical care. The primary objective of the study is to compare antibiotic use during hospitalisation between the intervention and control groups. Secondary objectives are to evaluate the safety of this approach by comparing mortality, hospital readmission within 28 days, adverse events, need for invasive ventilation, duration of hospitalisation, and other clinical outcomes between study groups. In addition, the study will compare healthcare-related costs, including antibiotic expenditure and costs associated with hospitalisation. A parallel mixed-methods component will explore clinician attitudes, beliefs, and determinants of antibiotic prescribing for children hospitalised with LRTI using surveys, focus groups discussions, and individual interviews informed by the Theoretical Domains Framework (TDF). Findings will help identify behavioural and system-level factors that influence antibiotic prescribing and inform future antimicrobial stewardship interventions. This study aims to generate evidence on whether biomarker-guided and risk-stratified care can safely optimise antibiotic use among young African children hospitalised with LRTI while improving antimicrobial stewardship and reducing healthcare costs.

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.

Effect of AI-Assisted Discharge Education on Parents of Children With Bronchitis/Bronchiolitis

This randomized controlled trial aims to evaluate the effects of artificial intelligence-assisted discharge education on mothers of children hospitalized with bronchitis/bronchiolitis. A total of 162 mothers will be randomly assigned to one of three groups: AI-assisted written discharge education, AI-assisted video discharge education, or routine discharge education. The primary outcome will be mothers' knowledge of home care after discharge. Secondary outcomes will include anxiety, readiness for hospital discharge, and satisfaction with discharge education. The study hypothesizes that AI-assisted written and video discharge education will improve mothers' knowledge and readiness for discharge, reduce anxiety, and increase satisfaction compared with routine discharge education.

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.

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.

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.

Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial

The goal of this clinical trial is to find out at which lower limit for saturation (amount of oxygen in the blood) we can best give extra oxygen to children that have been admitted for shortness of breath. We hope to accomplish a shorter period of illness for these children and that they can be discharged home earlier. Participants will receive supplemental oxygen if their blood oxygen levels are below 88% or below 92%. After admission, (parents of) participating children will fill out questionnaires. We will compare the two groups on their hospitalization duration and recovery. In other words, is it better to maintain a lower limit of 88% saturation or a lower limit of 92% in children admitted for shortness of breath?

Comparison Between 2l vs 3l in HFNC During the Initial Management of Severe Bronchiolitis in Infants

The purpose of the study is to evaluate prospectively the clinical benefits of 2 different flow with High flow nasal canula (HFNC: 2l/kg/min) versus (HFNC: 2l/kg/min) in the initial management of bronchiolitis in infants. Design: Prospective, controlled, randomized, multi-center. Design: Infants less than 6 month admitted in pediatric intensive care unit for respiratory distress (mWCAS \>3) secondary to bronchiolitis but not requiring mechanical ventilation will be randomized in two groups:HFNC "2l/min/kg" or HFNC "3l/min/kg" during 24 hours. Conditions of measurements: Primary endpoint: Proportion of failure in both arms during the first 24 hours. Failure criteria: A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above 4) or apnea. Secondary outcomes: Assessment at H1, H12, H24 of mWCAS, respiratory and heart rate, EDIN score, skin lesions, FiO2 required to achieve an oxygen saturation between 94 and 97%, transcutaneous PCO2 (correlated to an initial gas analysis), Report SpO2 / FiO2 Statistic: Intention to treat Analysis. Expected number of patients: 135 per arm: 270 children.

Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis

This aim of this study is to measure the peak tidal inspiratory flow (PTIF), using spirometry, in young infants with moderate to severe acute viral bronchiolitis (AVB). PTIF is important to consider for the management of AVB with High Flow Nasal Cannulae (HFNC). Indeed, efficiency with HFNC is optimal provided that the settled flow is equal or higher than the patient's PTIF. However, PTIF values in infants with AVB have never been determined.

Assessment of Thoracic Echography for Pleuroparenchymatous Anomaly Diagnosis Complicating Bronchiolitis: BronchioIUS

The diagnosis of bronchiolitis, the most frequent lung infectious disease in infancy, is based on clinical examination. Chest X-ray is proposed when a lung parenchymal condensation is suspected. Chest ultrasound is supposed to be a useful tool in the diagnosis of these complication but is poorly evaluated. We aim to compare chest X-ray and chest ultrasound for the diagnosis of parenchymal condensation in infant with bronchiolitis.

Etude PROTECT : Prognostic Role of Tapse Evaluation in Children's bronchioliTis

In this prospective study, we aim to evaluate the association between an echocardiographic marker of right ventricular systolic function, the TAPSE (Tricuspid Annular Plane Systolic Excursion), and poor outcome in patients admitted to Pediatric Intensive Care Unit (PICU) for Acute Bronchiolitis (AB).

Transplacental Transmission of RSV (TTRSV)

Aim 1: To study transplacental transmission of Respiratory Syncytial Virus (RSV) and how this is moderated by other maternal infections during pregnancy Aim 2: To test maternal blood for presence of RSV-specific immunoglobulins and how this is moderated by other maternal infections during pregnancy Aim 3: To test cord blood (fetal blood) for presence of RSV-specific immunoglobulins and other common viral pathogens Aim 4: To perform further tests (Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), Droplet Digital Polymerase Chain Reaction (ddPCR) and immunoprobing) to confirm the presence of RSV and other common viral pathogens Aim 5: To follow these newborn infants up to 4 years of age to look for redisposition to respiratory diseases and growth parameters

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.

Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children

This study's objective is to identify and test pragmatic and sustainable strategies for implementing a multi-condition clinical pathway intervention for children hospitalized with asthma, pneumonia, or bronchiolitis in community hospitals. The hypothesis is that the multi-condition pathway intervention will be associated with significantly greater increases in clinicians' adoption of evidence-based practices compared to control. The study is a pragmatic, cluster-randomized trial in US community hospitals. The primary outcome will be adoption of evidence-based practices over a sustained period of 2 years. Secondary outcomes include length of hospital stay, intensive care unit transfer, and hospital readmission/emergency department revisit.

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.

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.

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

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.

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.