Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis

Bronchiolitis Clinical Trial

Official title:

A Randomized Controlled Trial of Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02834819
• Other study ID #: 13-0092
• Status: Terminated
• Phase: N/A
• Start date: September 2013
• Est. completion date: September 2015

Study information

• Verified date: February 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether nebulized 3% hypertonic saline is more effective than the current standard of care in the treatment of viral bronchiolitis in children.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Drug:
• 3% Nebulized Hypertonic Saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

References & Publications (10)

American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006 Oct;118(4):1774-93. — View Citation

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. — View Citation

Mai XM, Nilsson L, Kjellman NI, Björkstén B. Hypertonic saline challenge tests in the diagnosis of bronchial hyperresponsiveness and asthma in children. Pediatr Allergy Immunol. 2002 Oct;13(5):361-7. — View Citation

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. — View Citation

Pelletier AJ, Mansbach JM, Camargo CA Jr. Direct medical costs of bronchiolitis hospitalizations in the United States. Pediatrics. 2006 Dec;118(6):2418-23. — View Citation

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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2018 Sep 27;9:CD001506. — View Citation

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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2013;7:CD006458. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization Rate	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.
Primary	Number of Patients With Persistent Hypoxia	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
Primary	Need for Supplemental Oxygen After Discharge	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	Pre- Intervention Clinical Severity Score	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.
Secondary	Post-intervention Clinical Severity Score	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
Secondary	Unscheduled Return ED Visits	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
Secondary	Adverse Outcomes	Respiratory distress, increased oxygen requirement, advanced airway interventions (NIPPV or intubation).	During enrollment visit or within 7 days following enrollment visit
Secondary	Hospital Admission After Discharge	Admission to any hospital institution within 7 days following enrollment visit	Within 7 days following discharge from enrollment visit