Clinical Research Directory

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.

Impact of a Multimodal Intervention on Antibiotic Prescribing for Respiratory Infections in Primary Care

Antimicrobial resistance (AMR), considered one of the greatest global threats by the WHO, justifies the development of initiatives to promote appropriate antibiotic use-especially in primary care, where most antibiotics in France are prescribed and where misuse remains common. We are proposing a cluster-randomized controlled trial to evaluate the effectiveness of a bimodal intervention combining: (1) improved communication about the circulation of respiratory viruses, and (2) strengthened collaborative practices between general practitioners and pharmacists through a multidisciplinary protocol aimed at verifying that prescribed treatment durations comply with guidelines. The study will include six primary care practices (24 physicians), with three practices in each study arm. The aim of this project is to assess whether the bimodal intervention can reduce the duration of antibiotic treatments for upper and lower respiratory tract infections. The first component (a "viral infection prescription" tool) focuses on reducing unnecessary treatment initiation, while the second (pharmacist-led review) aims to shorten excessive prescription durations.

High Flow Nasal Cannula Weaning in Acute Bronchiolitis

The goal of this clinical study is to compared two different strategies to end high flow nasal cannula treatment in acute bronchiolitis. This study compared the immediate ending of high flow treatment to weaning strategy, in which the flow rate is gradually decreased. The aim is to assess if the immediate ending shortens the hospitalization time and whether it is a safe strategy.

Nebulized 3% Hypertonic Saline Versus Normal Saline in Managing Children With Acute Bronchiolitis: A Randomized Controlled Trial

This randomized controlled trial was conducted at A-Ramadi Teaching Hospital for Maternity and Children on patients admitted with acute bronchiolitis. The study covered a duration of 6 months. The study was approved by the Ethical Approval Committee of the University of Anbar. Informed consent was obtained from each parent. The severity of bronchiolitis was assessed based on the absence (score = 0) or presence (score = 1) of the following parameters: tachycardia, wheezing, use of accessory muscles, low oxygen saturation (SpO₂ \< 95%), and feeding difficulties. The total score, therefore, ranged from 0 to 5. Severity was subsequently classified into three categories: Mild (0-1), patients typically discharged home without the need for hospitalization; Moderate (2-3), patients admitted to the general pediatric ward for closer observation and supportive care; and Severe (4-5), patients requiring admission to the PICU due to significant respiratory compromise, such as oxygen saturation \< 90%, intercostal recession, and wheezing requiring respiratory support \[15\]. All patients aged 0-24 months with a clinical diagnosis of bronchiolitis, defined by signs of acute respiratory distress, chest radiographic findings consistent with bronchiolitis, and a bronchiolitis severity score of (2-3), whose parents or guardians provided informed consent were enrolled in the study. Exclusion criteria were: severely ill infants requiring mechanical ventilation; age greater than 2 years; presence of chronic illnesses such as chronic renal disease, congenital heart disease, or neuromuscular disorders; immunocompromised status (including malnutrition or chronic corticosteroid use); diagnosis of asthma; prior use of corticosteroids or bronchodilators; and refusal of caregivers to participate in the trial. We calculate the required sample size according to the mean LOS of 3 days from a previous study \[5\] and aimed to detect a clinically meaningful 25% reduction (\~0.75 days), with a standard deviation of 1.92 days, 90% power, and a two-sided alpha of 0.05. Using the two-sample t-test formula for comparing means, this resulted in approximately 139 patients per group, which was increased to 150 per group to account for potential dropouts. Eligible patients with moderate bronchiolitis who met the inclusion criteria were randomly assigned in a 1:1 ratio to either the hypertonic saline (3%) group or the normal saline (0.9%) group. Randomization was performed using a computer-generated random number sequence prepared by an independent statistician not involved in patient recruitment or treatment. Allocation concealment was ensured through the use of sequentially numbered, opaque, sealed envelopes, which were opened only after patient enrollment and completion of baseline assessments. Due to the physical characteristics of the solutions, blinding of the nursing staff administering the nebulization was not feasible. However, the physicians responsible for clinical assessment and outcome evaluation were blinded to the treatment allocation to minimize observer bias. Parents or guardians were not informed of the specific solution used, and both groups received nebulization with an identical-appearing setup to maintain partial blinding at the patient and caregiver level. Patients with moderate bronchiolitis were randomly allocated into two groups. The first group received 3% hypertonic saline as a diluent with salbutamol, whereas the second group received 0.9% normal saline as a diluent with salbutamol. Nebulization was administered via a compressed air-driven jet nebulizer four times daily by well-trained nursing staff under the supervision of on-call physicians. All other aspects of bronchiolitis management were provided similarly to both groups, including oxygen supplementation to maintain SpO₂ \> 92%, airway suctioning, nebulization with salbutamol, and corticosteroid therapy. A follow-up flow chart was maintained for direct monitoring of each patient's clinical symptoms and signs of respiratory distress. Baseline clinical symptoms, vital signs, and respiratory severity scores were recorded for all participants at admission before initiation of the treatment protocol. Data were analyzed using the Statistical Package for the Social Sciences software, version 29. Continuous variables were tested for normality using the Shapiro-Wilk test. Normally distributed data were expressed as mean±SD and compared between groups using the independent samples t-test. Non-normally distributed variables were presented as median and analyzed using the Mann-Whitney U test. Categorical variables were presented as frequencies and percentages, and differences between groups were assessed using the chi-square test or Fisher's exact test, as appropriate. The primary outcome was the difference in LOS between the two groups. Secondary outcomes included changes in respiratory severity score, oxygen saturation, and the proportion of patients progressing to severe disease.

Viral Epidemiology of Bronchiolitis After Nirsevimab Implementation and Respiratory Evolution in Infants

Acute bronchiolitis in infants, mainly caused by the Respiratory Syncytial Virus (RSV), is a public health issue, in terms of morbidity and hospital costs. Nirsevimab, a long-acting antibody against RSV available for all infants under 12 months, could profoundly modify the epidemiology of the next epidemic seasons, with the increase of the frequency of the other respiratory viruses (endemic Coronaviruses, Metapneumovirus, etc) Monitoring viral ecology is important, as the impact of respiratory infections on morbidity in the short, medium and long term, but also in economic terms. Infants under the age 12 months with a first episode of bronchiolitis and consulting the emergency pediatric department will be included. A nasopharyngeal swab will be performed as routine care, and clinical data will be collected. Multiplex Polymerase Chain Reaction will be performed to identify respiratory virus(es) responsible for the bronchiolitis. In hospitalized infants with RSV or rhinovirus positive Polymerase Chain Reaction (PCR), daily nasal washes will be collected to perform viral loads with specific quantitative PCR (nasal washes biobank), associated with daily clinical data. A 12-month follow-up is planned for every infant included, consisting with 4 phone calls, to identify factors associated with the onset of preschool wheezing. The main objective is to describe the viral epidemiology associated with acute bronchiolitis leading to a pediatric emergency department visit the implementation of Nirsevimab.