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Heated Humidified Oxygen Compared to Dry Oxygen Therapy in Children With Bronchiolitis

Primary Purpose

Bronchiolitis, Hypoxemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heated and humidified oxygen
Sponsored by
UCSF Benioff Children's Hospital Oakland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Heat, Humidification, Oxygen

Eligibility Criteria

undefined - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages ≤24 months of age
  • Physician diagnosed bronchiolitis
  • Admitted to pediatric floor
  • Supplemental oxygen requirement, <4 L/min, for hypoxemia, oxygen saturation <92% in room air

Exclusion Criteria:

  • Prematurity, born <37 weeks gestational age
  • Admitted to pediatric intensive care unit for medical indication
  • Requirement of heated, humidified high flow system
  • Chronic lung disease (such as bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia, tracheostomy status, baseline oxygen requirement)
  • Neuromuscular disorders
  • Chromosomal defects
  • Metabolic disorders
  • Immunodeficiency
  • Unrepaired cardiac abnormalities

Sites / Locations

  • Children's Hospital and Research Center Oakland

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard oxygen via nasal cannula

Heated and humidified oxygen

Arm Description

Standard therapy

Heated and humified oxygen

Outcomes

Primary Outcome Measures

Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline.
The RDAI is a validated clinical scoring system to assess respiratory distress and has been used in several bronchiolitis studies. The RDAI is based on two variables, wheezing and retractions, in which points are applied to each to give a score ranging from 0 to 17. The higher the total score, the worse the subject was clinically. Reported are the absolute scores at each time point, for each arm. Baseline scores are reported in the Baseline Module.
Change in Respiratory Rate (RR) From Baseline
Respiratory rate was measured by counting respirations for one minute. Reported are the absolute scores at each time point, for each arm. Baseline scores are reported in the Baseline Module.

Secondary Outcome Measures

Length of Hospital Stay
Length of hospital stay is measured in days and counted from day of admission to day of discharge.
Duration of O2 Use
Duration on supplemental O2 was measured in hours.

Full Information

First Posted
March 18, 2014
Last Updated
January 5, 2018
Sponsor
UCSF Benioff Children's Hospital Oakland
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1. Study Identification

Unique Protocol Identification Number
NCT02094664
Brief Title
Heated Humidified Oxygen Compared to Dry Oxygen Therapy in Children With Bronchiolitis
Official Title
HHOT AIR Study (a Pilot Study): Heated Humidified Oxygen Therapy Compared to Standard Dry Oxygen: An Assessment in Infants With bRonchiolitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UCSF Benioff Children's Hospital Oakland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare heat and humidified oxygen with cold and dry oxygen in children with bronchiolitis. The hypotheses are that heating and humidifying inspired low flow supplemental oxygen will optimize mucociliary function thereby, 1) improve oxygenation, 2) decrease work of breathing, and 3) decrease length of hospital stay.
Detailed Description
Bronchiolitis is the leading cause of acute respiratory illness and hospitalization in infants and young children. The mainstay of treatment is supportive care, which includes frequent nasal suctioning, intravenous fluid hydration, and supplemental oxygen for hypoxemia. The airways normally heat and humidify inspired ambient air to core temperature amd 100% relative humidity at the carina. This environment, at core temperature, allows for optimal mucociliary clearance. Supplemental oxygen delivered via wall source is cold and dry, and does not reach core temperature and 100% humidity until some point distal to the carina, past the main bronchi. This presses on the lower respiratory tract to assist in heat and moisture exchange and thus decrease ciliary function. This, in combination with bronchiolitis, can impair mucociliary clearance. Specific aim 1: Determine the effect of heated and humidified oxygen therapy on clinical improvement in children with bronchiolitis, based on Respiratory Distress Assessment Instrument (RDAI) and respiratory rate (RR). Specific aim 2: Determine the effect of heated and humidified oxygen therapy on length of hospital stay and duration of supplemental oxygen requirement in children with bronchiolitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis, Hypoxemia
Keywords
Heat, Humidification, Oxygen

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard oxygen via nasal cannula
Arm Type
No Intervention
Arm Description
Standard therapy
Arm Title
Heated and humidified oxygen
Arm Type
Active Comparator
Arm Description
Heated and humified oxygen
Intervention Type
Device
Intervention Name(s)
Heated and humidified oxygen
Primary Outcome Measure Information:
Title
Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline.
Description
The RDAI is a validated clinical scoring system to assess respiratory distress and has been used in several bronchiolitis studies. The RDAI is based on two variables, wheezing and retractions, in which points are applied to each to give a score ranging from 0 to 17. The higher the total score, the worse the subject was clinically. Reported are the absolute scores at each time point, for each arm. Baseline scores are reported in the Baseline Module.
Time Frame
Baseline, Hour 1, Hour 4, Hour 8, and Hour 12
Title
Change in Respiratory Rate (RR) From Baseline
Description
Respiratory rate was measured by counting respirations for one minute. Reported are the absolute scores at each time point, for each arm. Baseline scores are reported in the Baseline Module.
Time Frame
Baseline, Hour 1, Hour 4, Hour 8, and Hour 12
Secondary Outcome Measure Information:
Title
Length of Hospital Stay
Description
Length of hospital stay is measured in days and counted from day of admission to day of discharge.
Time Frame
Subjects will be followed for the duration of hospital stay until discharge
Title
Duration of O2 Use
Description
Duration on supplemental O2 was measured in hours.
Time Frame
Subjects will be followed for the duration of oxygen requirement until oxygen discontinued

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages ≤24 months of age Physician diagnosed bronchiolitis Admitted to pediatric floor Supplemental oxygen requirement, <4 L/min, for hypoxemia, oxygen saturation <92% in room air Exclusion Criteria: Prematurity, born <37 weeks gestational age Admitted to pediatric intensive care unit for medical indication Requirement of heated, humidified high flow system Chronic lung disease (such as bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia, tracheostomy status, baseline oxygen requirement) Neuromuscular disorders Chromosomal defects Metabolic disorders Immunodeficiency Unrepaired cardiac abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Chen, M.D.
Organizational Affiliation
UCSF Benioff Children's Hospital Oakland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital and Research Center Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States

12. IPD Sharing Statement

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Heated Humidified Oxygen Compared to Dry Oxygen Therapy in Children With Bronchiolitis

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