Recruiting

Standard & Positive Pressure Nebulization

Sponsor:

Phoenix Children's Hospital

Code:

NCT01229384

Conditions

Bronchiolitis

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Accepted

Interventions

Positive Airway Pressure nebulization

Standard passive nebulization of respiratory medications

Study Details

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.

Conditions

Bronchiolitis

Study ID

NCT01229384

Start date

Oct, 2011

Status verified date

Jun, 2012

Completion date

Mar, 2013

Anticipated

Primary completion date

Mar, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Positive Airway Pressure Nebulization

Will administer nebulized medications using Positive Airway Pressure Nebulization

active comparator: Standard Nebulization

Current standard of administering nebulized medications without positive airway pressure

Interventions

Positive Airway Pressure nebulization

Using a device approved in pediatrics to deliver nebulized treatments of albuterol and racemic epinephrine with positive pressure

Standard passive nebulization of respiratory medications

Patients will receive standard passively inhaled nebulized albuterol and racemic epinephrine.

Primary outcome measure

  • Hospitalization Rates [ Time Frame: 2 weeks ]

Central Contacts and Locations

Locations

Phoenix Children's Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Principal Investigator:

Zebulon J Timmons, BA, MD

More Information

Sponsor

Phoenix Children's Hospital

Last update posted

Jun 11, 2012

Last verified

Jun, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Phoenix Children's Hospital on 2012-06-11.