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

NCT07505420 | Not Yet Recruiting

• 1 other identifier: Pediatric Bronchiolitis Burden
• Study Type: observational
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bronchiolitis; Acute Bronchiolitis; Respiratory Syncytial Virus Infection

Keywords

Bronchiolitis; Acute Bronchiolitis; Respiratory Syncytial Virus Infections; Lower Respiratory Tract Infection; Respiratory Tract Infections; Viral Respiratory Infection; Wheezing; Respiratory Distress

Outcome Measures

Primary Outcomes (1)

• 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.

  At hospital admission (Day 0)

Study Arms (1)

Hospitalized Children with Acute Bronchiolitis

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.

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Children aged 1-24 months presenting with acute bronchiolitis, defined per AAP 2014 criteria: preceding upper respiratory infection, wheezing, tachypnoea (\>60 breaths/min \<2 months, \>50 \<12 months, \>40 \>12 months), and signs of respiratory distress (nasal flaring, grunting, retractions).
• Confirmed clinical diagnosis by a pediatric pulmonologist.

You may not qualify if:

• Known congenital heart disease, chronic lung disease (e.g., bronchopulmonary dysplasia), immunodeficiency, or neuromuscular disorders.
• Recurrent wheezing suggesting asthma.
• Gestational age \<32 weeks without recovery or birth weight \<1500g without catch-up growth.
• Immunosuppression, recent (within 2 weeks) systemic steroids or antibiotics.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Bronchiolitis; Respiratory Syncytial Virus Infections; Respiratory Tract Infections; Respiratory Sounds; Dyspnea

Condition Hierarchy (Ancestors)

Bronchitis; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Pediatric Department, Assiut University

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03