An observational study in Bronchiolitis, Acute Bronchiolitis and Respiratory Syncytial Virus Infection, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Month to 24 Months. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Assiut University · Observational
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:
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.
Acute bronchiolitis represents the most common lower respiratory tract infection in children under two years of age, imposing a substantial healthcare burden, particularly in low-resource settings. The severity of the disease hinges on a combination of host factors (such as prematurity, low birth weight, and lack of exclusive breastfeeding) and environmental exposures (including passive smoking, crowded living conditions, and low socioeconomic status). This prospective observational cohort study aims to identify and quantify these risk factors and determine their impact on clinical outcomes for patients admitted to Assiut University Hospital.
Upon hospital presentation and confirmation of eligibility, a structured questionnaire will be administered to the parents or guardians to collect comprehensive sociodemographic data, including parental education, occupation, and specific infant feeding practices. Concurrently, a pediatrician will conduct a standardized clinical assessment to evaluate the presence and severity of respiratory signs, such as tachypnea, retractions, accessory muscle use, nasal flaring, grunting, and baseline oxygen saturation levels.
Throughout the patient's hospital stay, the research team will document diagnostic investigation patterns to evaluate adherence to evidence-based guidelines. This includes tracking the utilization of routine blood analyses (Complete Blood Count, C-reactive protein, Arterial Blood Gas) and radiological evaluations (Chest X-ray), which are typically discouraged for routine use but may be utilized for suspected complications.
Furthermore, clinical management strategies will be closely monitored and recorded. The research team will track the escalation of oxygen therapy, ranging from low-flow nasal cannula to high-flow nasal cannula (HFNC) and continuous positive airway pressure (CPAP/BiPAP), as well as feeding support interventions, such as nasogastric tube feeding requirements. Data will be statistically analyzed to assess the prevalence of modifiable risk factors and correlate these variables with the overall length of stay, intensive care needs, mechanical ventilation requirements, and 30-day readmission rates.
289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.
This study's planned enrollment of 65 is below the median of 200 across 79 observational studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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The study population consists of hospitalized children aged 1 to 24 months presenting with acute bronchiolitis at Assiut University Hospital. Patients are eligible if they have a clinical diagnosis confirmed by a pediatric pulmonologist according to the AAP 2014 criteria, presenting with a preceding upper respiratory infection, wheezing, tachypnea, and signs of respiratory distress. The population strictly excludes children with underlying comorbidities that might independently affect respiratory severity, including known congenital heart disease, chronic lung disease, immunodeficiencies, and neuromuscular disorders. Furthermore, patients with a history of recurrent wheezing, extreme prematurity (gestational age \<32 weeks without recovery) or low birth weight (\<1500g without catch-up growth), and those who have received systemic steroids or antibiotics within the past two weeks are excluded from the study cohort.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children aged 1 to 24 months presenting to Assiut University Hospital with a confirmed clinical diagnosis of acute bronchiolitis per AAP 2014 criteria. This single cohort will be prospectively observed to identify and quantify risk factors associated with disease severity, including sociodemographic factors, feeding practices, and clinical assessments. Data collected will include hospitalization rates, ICU admissions, length of stay, and clinical management strategies such as oxygen therapy escalation and feeding support. As an observational study, no experimental interventions will be administered; patients will receive standard care.
Bronchiolitis Clinical Severity Score
Disease severity will be assessed upon hospital presentation using a standardized clinical scoring tool. The tool yields a single total score based on the clinical evaluation of respiratory parameters. A total score of 8 or higher categorizes the participant as having severe bronchiolitis.
Time frame: At hospital admission (Day 0)
No study locations are listed for this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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