- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02834819
Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis
A Randomized Controlled Trial of Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This will be a prospective, randomized controlled single-blinded study of patients 3-18 months of age presenting to the Children's Hospital Colorado ED during bronchiolitis season, diagnosed with mild to moderate bronchiolitis and persistent hypoxia and started on the Children's Hospital Colorado Home Oxygen pathway (see attached clinical care guideline). Investigators aim to enroll 220 patients. Patients will be identified by research assistants in the ED, based on physician diagnosis of bronchiolitis, with hypoxia requiring < 0.5L oxygen by NC. A research assistant will approach the family and go through the informed consent process. If consent is obtained, the patient will then be randomized to one of the two study arms via a computer generated randomization table. In order to arrange for respiratory therapy, the research assistants will not be blinded. There will be an age block randomization scheme, and therefore patients aged 3-12 months will be randomized separately from patients 12.1-18 months to ensure equal distribution of age ranges in each arm.
The experimental arm will consist of patients who receive a nebulized treatment of 4ml of 3% hypertonic saline, administered by a respiratory therapist, as well as supportive care as needed. Patients in the control arm will receive supportive care only, the current standard of care at Children's Hospital Colorado. The pharmacist will randomize patients as noted above. After consent is obtained the provider will perform a pre-intervention clinical severity score evaluation to patients in both study arms utilizing the clinical severity score tool described by Wang et al.19 Respiratory therapy will then provide the nebulized treatment for those patients randomized to receive hypertonic saline. Removal of equipment following treatment will aid in ensuring blinding of physicians to treatment arm. At 90 minutes after treatment with hypertonic saline or after the order is placed for patients in the control arm, patients in both arms will undergo a second clinical severity score by the provider. At that time the provider will turn off the oxygen administered to both treatment arms for a room air challenge. The RN will be notified that the patients are off oxygen therapy and will restart oxygen if patient has saturations < 87% (as indicated by continuous pulse oximetry) and oxygen will be restarted at 0.5L by NC.
Patients in both arms who are no longer requiring oxygen will be observed for a minimum of 4 hours to ensure they remain stable on room air, have appropriate oral intake, and sleep without de-saturation. At any point if a patient who was weaned off oxygen becomes hypoxic (saturations < 87%), requiring < 0.5L oxygen NC they will return to the home oxygen observation protocol. If during this period of observation any patient requires > 0.5L oxygen during wake or sleep periods, is not taking adequate oral intake, demonstrates respiratory distress, or at physician discretion, patient may be admitted to the inpatient service for further management.
Patients in both arms will receive follow-up phone calls to assess duration and amount of oxygen, as well as adverse outcomes. Patients discharged home on room air will receive 1 phone call on post-discharge day #7 (range 6-8). Patients discharged home on oxygen will receive a phone call on day #7 (range 6-8). Calls will be made for the study by the study investigators or by the Emergency Department (ED) research assistants. During the follow-up phone call, caregivers will be asked about Primary Care Physician (PCP) follow-up visits, any future scheduled PCP visits, any adverse events including increased work of breathing, increased oxygen requirement, repeat ED visits to researchers or other institutions, outside hospital admissions, intensive care unit admission or intubations, and any instructions for weaning oxygen given by PCP. If parents have questions or concerns, these questions will be directed to a nurse, fellow, or attending provider.
Data from each subject will be collected on a data collection sheet for the follow-up phone call and PCP call. Data will then be entered into a database on a secure server and de-identified. All identifiers will be removed from the data set.
The Electronic Health Record will be reviewed to verify return visits. If return visits are documented in EPIC (electronic health records software), data on type of admission (general pediatrics or intensive care unit) and any advanced airway intervention such as intubation, continuous positive airway pressure (CPAP).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients presenting to Children's Hospital Colorado ED
- ≥3 to ≤18 months of age
- Diagnosed with bronchiolitis
- Have persistent hypoxia following initial supportive care measures as outlined by Children's Hospital Colorado Bronchiolitis Clinical Care Guideline
- Started on Children's Hospital Colorado Home Oxygen Pathway
Exclusion Criteria:
- Patients who do not qualify for the Clinical Care Guideline for Home oxygen for Bronchiolitis
- Previous history of wheezing
- History of reactive airway disease
- History of underlying heart disease
- Require >0.5L oxygen
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Hypertonic Saline
Patients randomized to the hypertonic saline group will be administered one nebulized treatment of 3% hypertonic saline.
They will also receive what is considered standard of care, which includes suctioning and supportive care as needed.
|
|
NO_INTERVENTION: No treatment
Patients in the "No treatment" arm will receive no additional treatment other than standard of care, which includes suctioning and supportive care as needed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospitalization Rate
Time Frame: At any point during enrollment visit or up to 7 days after enrollment visit.
|
Effect of nebulized 3% hypertonic saline on hospitalization rate in children with bronchiolitis compared to those who receive the current standard of care
|
At any point during enrollment visit or up to 7 days after enrollment visit.
|
Number of Patients With Persistent Hypoxia
Time Frame: At baseline and 90 minutes post-intervention
|
To assess the effect of nebulized hypertonic saline on hypoxia in children with bronchiolitis compared to those who receive current standard of care.
|
At baseline and 90 minutes post-intervention
|
Need for Supplemental Oxygen After Discharge
Time Frame: At time of discharge from the hospital through 7 days.
|
To assess the effect of nebulized hypertonic saline on supplemental home oxygen requirement in children with bronchiolitis compared to those who receive the current standard of care.
|
At time of discharge from the hospital through 7 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre- Intervention Clinical Severity Score
Time Frame: During Enrollment visit following randomization.
|
Clinical severity score taken immediately following randomization, and prior to any intervention to assess change in baseline after intervention and compare change in scores, if any, between the two groups.
The Scale utilized was the Clinical Severity Score from Wang et al, which measures respiratory distress in young children.
The system assigns scores ranging from 0 to 3 for the following categories: respiratory rate, wheezing, retraction, and general condition.
These category scores are then summed to come up with the final Clinical Severity Score.
Total scores range from 0 to 12, with higher scores indicating greater severity/worse outcomes.
|
During Enrollment visit following randomization.
|
Post-intervention Clinical Severity Score
Time Frame: During enrollment visit - 90 minutes after randomization
|
Clinical severity score taken at time 90 minutes in both arms to assess any change in clinical severity score from baseline.
The Scale utilized was the Clinical Severity Score from Wang et al, which measures respiratory distress in young children.
The system assigns scores ranging from 0 to3 for the following categories: respiratory rate, wheezing, retraction, and general condition.
These category scores are then summed to come up with the final Clinical Severity Score.
Total scores range from 0 to 12, with higher scores indicating greater severity/worse outcomes.
|
During enrollment visit - 90 minutes after randomization
|
Unscheduled Return ED Visits
Time Frame: Called at 7 days post enrollment visit to assess any visit within 3 days of enrollment visit
|
Unscheduled visit to ED within 3 days of enrollment visit. Patients in each group will be contacted 7 days after the enrollment visit to see if they had any unscheduled return ED visit within 3 days of the enrollment visit. |
Called at 7 days post enrollment visit to assess any visit within 3 days of enrollment visit
|
Adverse Outcomes
Time Frame: During enrollment visit or within 7 days following enrollment visit
|
Respiratory distress, increased oxygen requirement, advanced airway interventions (NIPPV or intubation).
|
During enrollment visit or within 7 days following enrollment visit
|
Hospital Admission After Discharge
Time Frame: Within 7 days following discharge from enrollment visit
|
Admission to any hospital institution within 7 days following enrollment visit
|
Within 7 days following discharge from enrollment visit
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cortney Braund, MD, University of Colorado, Denver
Publications and helpful links
General Publications
- Zorc JJ, Hall CB. Bronchiolitis: recent evidence on diagnosis and management. Pediatrics. 2010 Feb;125(2):342-9. doi: 10.1542/peds.2009-2092. Epub 2010 Jan 25.
- American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006 Oct;118(4):1774-93. doi: 10.1542/peds.2006-2223.
- Yorita KL, Holman RC, Sejvar JJ, Steiner CA, Schonberger LB. Infectious disease hospitalizations among infants in the United States. Pediatrics. 2008 Feb;121(2):244-52. doi: 10.1542/peds.2007-1392.
- Kini NM, Robbins JM, Kirschbaum MS, Frisbee SJ, Kotagal UR; Child Health Accountability Initiative. Inpatient care for uncomplicated bronchiolitis: comparison with Milliman and Robertson guidelines. Arch Pediatr Adolesc Med. 2001 Dec;155(12):1323-7. doi: 10.1001/archpedi.155.12.1323.
- Pelletier AJ, Mansbach JM, Camargo CA Jr. Direct medical costs of bronchiolitis hospitalizations in the United States. Pediatrics. 2006 Dec;118(6):2418-23. doi: 10.1542/peds.2006-1193.
- Mallory MD, Shay DK, Garrett J, Bordley WC. Bronchiolitis management preferences and the influence of pulse oximetry and respiratory rate on the decision to admit. Pediatrics. 2003 Jan;111(1):e45-51. doi: 10.1542/peds.111.1.e45.
- Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulized hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006458. doi: 10.1002/14651858.CD006458.pub2.
- Mai XM, Nilsson L, Kjellman NI, Bjorksten B. Hypertonic saline challenge tests in the diagnosis of bronchial hyperresponsiveness and asthma in children. Pediatr Allergy Immunol. 2002 Oct;13(5):361-7. doi: 10.1034/j.1399-3038.2002.01011.x.
- Wark P, McDonald VM. Nebulised hypertonic saline for cystic fibrosis. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD001506. doi: 10.1002/14651858.CD001506.pub3.
- Ralston S, Hill V, Martinez M. Nebulized hypertonic saline without adjunctive bronchodilators for children with bronchiolitis. Pediatrics. 2010 Sep;126(3):e520-5. doi: 10.1542/peds.2009-3105. Epub 2010 Aug 16.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-0092
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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