Prioritization of comparative effectiveness research topics in hospital pediatrics.
Ron Keren, Xianqun Luan, Russell Localio...
https://pubmed.ncbi.nlm.nih.gov/23027409/Actively Recruiting
Led by Nemours Children's Clinic · Updated on 2026-05-08
400
Participants Needed
1
Research Sites
52 weeks
Total Duration
Bronchiolitis is a common cause of illness in young children, leading to significant healthcare use. This research aims to understand how children with bronchiolitis respond to bronchodilator treatments like albuterol, focusing on differences in clinical features and genetics. The study explores whether certain genetic variants and physical signs linked to allergic tendencies can predict how well a child with bronchiolitis responds to bronchodilators. Children aged 3 to 24 months diagnosed with bronchiolitis will be randomly assigned to receive either a nebulized dose of albuterol sulfate or a placebo solution normal saline. This is a double-blind trial, meaning neither the participants nor the researchers know which treatment is given until after the study. The treatments will be prepared and stored securely in the emergency department. Participants will have their respiratory status assessed before and after the treatment. Researchers will collect samples including blood, urine, DNA from cheek swabs, and nasal swabs to study genetic and clinical responses. The main outcomes measured are changes in respiratory scores immediately after treatment and the relationship between genetic markers and bronchodilator response over about one year. The goal is to develop a prediction model combining clinical and genetic information to better identify children who may benefit from bronchodilator therapy.
CONDITIONS
Characterization of Bronchodilator Response in Children With Bronchiolitis Using Phenotypic and Genotypic Features
A
Andrea Rivera-Sepulveda, MD, MSc
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Nemours Children's Clinic
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Nebulized Albuterol Sulfate | Nebulized Normal Saline (Placebo) | Supportive Care (No Routine Bronchodilators) |
|---|---|---|---|
| What it is | Albuterol sulfate 2.5mg/3mL inhalation solution given via nebulizer in the emergency department to children with bronchiolitis. | Normal saline (0.9% sodium chloride) inhalation solution, also delivered via nebulizer in the same emergency department setting as a placebo. | Supportive care without routine bronchodilator administration for infants and young children with bronchiolitis. |
| Role in the trial | Investigational arm to assess the clinical response to nebulized albuterol in children with bronchiolitis. | Placebo comparator to control for the effect of nebulized therapy, enabling assessment of albuterol's clinical impact. | Current standard management for bronchiolitis in infants, focusing on supportive care and not using routine bronchodilator therapy. |
| Primary use or intent | To evaluate whether albuterol improves clinical symptoms in children with bronchiolitis. | To serve as a placebo for direct comparison of clinical outcomes with nebulized albuterol. | To support hydration, comfort, and oxygenation through non-pharmacologic measures. |
| How it is given or performed | Administered as a nebulized solution (2.5mg/3mL), inhaled through a mask or mouthpiece in the emergency department. | Administered as a nebulized solution (3mL 0.9% sodium chloride) in the emergency department, identical to the albuterol arm for blinding. | Supportive care typically includes supplemental oxygen if needed, suctioning of nasal secretions, and maintaining hydration, but does not involve routine nebulization of bronchodilators. |
| Evidence status | Prior meta-analyses and guidelines report no consistent and clinically meaningful benefit of routine albuterol use for bronchiolitis in young children. | Placebo, as an inert comparator, has no expected benefit for bronchiolitis symptoms. | Supportive care is the established approach; studies show that hydration, oxygen, and observation provide effective symptom management for most children. |
| Important limitations | Current evidence indicates limited or no meaningful benefit from routine albuterol use in bronchiolitis, though certain subgroups may warrant further investigation. | As a placebo, normal saline does not provide therapeutic benefit beyond the delivery of mist or comfort from nebulization. | Supportive care may not quickly relieve symptoms for all children and lacks a targeted medication for bronchiolitis itself. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single administration during the emergency department visit
Participants receive a nebulized inhalation solution of either albuterol sulfate or sodium chloride as part of the randomized treatment.
1 treatment visit (in-person)
Duration - Up to 1 year after treatment
Participants are monitored for clinical response and genetic outcomes after the treatment.
Periodic follow-up visits as scheduled
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor