BronchiolitisNCT07505420
Risk Factors and Severity of Bronchiolitis in Hospitalized Children at Assiut University Hospital
An observational study of Bronchiolitis and Acute Bronchiolitis, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Bronchiolitis, Acute Bronchiolitis, Respiratory Syncytial Virus Infection
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 24 months
- All sexes
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Clinical Epidemiology, Risk Factors Associated With Severity and Disease Burden of Bronchiolitis in Hospitalized Children in 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.
Read more
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.
Read the detailed description
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.
- Keywords
- Bronchiolitis, Acute Bronchiolitis, Respiratory Syncytial Virus Infections, Lower Respiratory Tract Infection, Respiratory Tract Infections, Viral Respiratory Infection, Wheezing, Respiratory Distress
- Medical subject headings
- Bronchiolitis, Respiratory Syncytial Virus Infections, Respiratory Tract Infections, Respiratory Sounds, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At hospital admission (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abdelregal Ahmed Mehanny, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505420
- Sponsor's protocol ID
- Pediatric Bronchiolitis Burden
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Epidemiology, Risk Factors Associated With Severity and Disease Burden of Bronchiolitis in Hospitalized Children in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT07505420
- Acronym / sponsor ID
- Pediatric Bronchiolitis Burden
- Keywords
- Bronchiolitis, Acute Bronchiolitis, Respiratory Syncytial Virus Infections, Lower Respiratory Tract Infection, Respiratory Tract Infections, Viral Respiratory Infection, Wheezing, Respiratory Distress
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bronchiolitis Clinical Severity Score
Time frame: At hospital admission (Day 0)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis and Acute Bronchiolitis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchiolitis Clinical Severity Score (time frame: At hospital admission (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.