Clinical trial NCT01229384: Randomized Controlled Trial Comparing Standard Versus Positive Pressure Nebulization in Infants With Bronchiolitis to Reduce Hospital Admissions
Official title: Randomized Controlled Trial Comparing Standard Versus Positive Pressure Nebulization in Infants With Bronchiolitis to Reduce Hospital Admissions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchiolitis
Lead sponsor: Phoenix Children's Hospital
Sponsor class: OTHER
First posted: 2010-10-27
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypothesis: That administration of nebulized therapy for bronchiolitis when using positive airway pressure is superior to standard mask ventilation in reducing hospital admissions.

Bronchiolitis is a lower respiratory tract infection (LRTI) syndrome caused by a variety of different viruses. It is the most common LRTI in children under 24 months old. Multiple studies have documented variation in treatment, hospitalization rates, and length of hospital stay for bronchiolitis, suggesting a lack of consensus and an opportunity to improve care for this common disorder.

Research to determine optimal delivery methods of respiratory medications that may augment oxygenation by decreasing atelectasis (Lung cell collapse) and increasing oxygen saturation have not been done. Currently bronchodilators are delivered through a passive process, inhaled as they are nebulized (made from liquid into gas) into a face mask. This study will evaluate whether using a newly developed positive pressure nebulization device that uses pressure to expand lung cells and, hypothetically, deliver the medication better, improves oxygenation by reducing atelectasis (lung cell collapse) to decrease hospitalization in infants with moderate to severe bronchiolitis.

Positive pressure nebulization is a relatively new adaptation of a previously existing modality, and is already currently in use here at PCH.


Eligibility criteria: Inclusion Criteria:

* Infants 2-24 months with moderate to severe bronchiolitis

Exclusion Criteria:

* Those outside the age range of 2-24 months, or less than postconceptual age of 48weeks for premature infants
* Those with comorbid conditions such as cyanotic heart disease, home oxygen use, tracheostomy use, or other serious medical conditions.
* Those with history of apnea

Primary outcomes:
measure: Hospitalization Rates
timeFrame: 2 weeks
Secondary outcomes:
measure: Change in bronchiolitis Score
timeFrame: day of presentation
measure: Change in Oxygen Saturation
timeFrame: Day of presentation
measure: Intensive Care Unit Admission Rate
timeFrame: day of presentation
measure: Length of Stay
timeFrame: To be determined
measure: Unscheduled Return to the Emergency Department
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
Study officials:
affiliation: Phoenix Children's Hospital
name: Zebulon J Timmons, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Phoenix Children's Hospital
name: Mark Hostetler, MD
role: STUDY_DIRECTOR
References: