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

NCT02094664 | Completed Results DMC

• 1 other identifier: 2013-066
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis; Hypoxemia

Keywords

Heat; Humidification; Oxygen

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, Hour 1, Hour 4, Hour 8, and Hour 12

• 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.

  Baseline, Hour 1, Hour 4, Hour 8, and Hour 12

Secondary Outcomes (2)

• Length of Hospital Stay

  Subjects will be followed for the duration of hospital stay until discharge

• Duration of O2 Use

  Subjects will be followed for the duration of oxygen requirement until oxygen discontinued

Study Arms (2)

Standard oxygen via nasal cannula

NO INTERVENTION

Standard therapy

Heated and humidified oxygen

ACTIVE COMPARATOR

Heated and humified oxygen

Device: Heated and humidified oxygen

Interventions

Heated and humidified oxygen DEVICE

Heated and humidified oxygen

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCSF Benioff Children's Hospital Oakland: lead

Study Sites (1)

Children's Hospital and Research Center Oakland

Oakland, California, 94609, United States

Location

MeSH Terms

Conditions

Bronchiolitis; Hypoxia

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Diana Chen
• Organization: UCLA Mattel Children's Hospital

dychen@mednet.ucla.edu

3108255930

Study Officials

• Diana Chen, M.D.

  UCSF Benioff Children's Hospital Oakland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Pulmonary Fellow

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 24, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 8, 2018
• Results First Posted: January 8, 2018

Record last verified: 2018-01

Locations

US (1)