JAMA Pediatrics Journal Club Slides:
Nebulized Hypertonic Saline for Bronchiolitis
Florin TA, Shaw KN, Kittick M, Yakscoe S, Zorc JJ. Nebulized
hypertonic saline for bronchiolitis in the emergency department: a
randomized clinical trial. JAMA Pediatr. Published online May 26,
2014. doi:10.1001/jamapediatrics.2013.5306.
Copyright restrictions may apply
Introduction
•
Background
– Acute bronchiolitis is the most frequent lower respiratory infection and
most frequent cause for hospitalization in infants.
– There are no proven effective therapies for bronchiolitis; nebulized
hypertonic saline (HS) has been proposed as a potential therapy.
– HS is thought to increase mucociliary clearance by lowering the
viscosity of mucus secretions, stimulating cilial beat, and reducing
airway edema.
– There is conflicting evidence about the role of HS for the treatment of
acute bronchiolitis.
•
Study Objective
– To determine whether nebulized 3% HS compared with normal saline
(NS) improves respiratory distress in infants with bronchiolitis not
responding to a trial of nasal suctioning and nebulized albuterol sulfate
in the emergency department (ED).
Copyright restrictions may apply
Methods
•
Study Design
– Randomized clinical trial with blinding of investigators, health care
providers, and parents.
•
Setting
– A single urban tertiary care pediatric ED during 2 bronchiolitis seasons,
from November 1 to April 30 of 2010 and 2011.
•
Patients
– Inclusion: (1) Aged 2 to <24 months, (2) first episode of bronchiolitis
(wheezing with signs and symptoms of respiratory distress and upper
respiratory infection), (3) Respiratory Distress Assessment Instrument
(RDAI) score of 4-15 after albuterol treatment.
– Exclusion: (1) History of wheezing or asthma, or bronchodilator therapy
before current illness, (2) chronic lung or heart disease, (3) critical
illness, (4) inability to receive nebulized medications, (5) non–Englishspeaking guardians.
Copyright restrictions may apply
Methods
•
Interventions
– 4 mL of 3% HS vs 4 mL of NS.
•
Outcomes
– Primary: Respiratory Assessment Change Score (RACS) at 1 hour after
study intervention (RACS = change in RDAI score + standardized change
in respiratory rate; decrease in RACS signifies clinical improvement).
– Secondary: Vital signs, oxygen saturation, hospitalization, physician
clinical impression, parental perception of improvement, adverse events.
Respiratory Distress Assessment Instrument
(adapted from Lowell et al22)
Copyright restrictions may apply
Results
Consolidated Standards for Reporting of Trials Study Flow Diagram
Copyright restrictions may apply
Results
Baseline Characteristics
Copyright restrictions may apply
Results
RACS Values 1 Hour After HS and NS Administration
Using a RACS of −3 as a clinically significant improvement, the NS
group demonstrated improvement in respiratory status 1 hour after
treatment, and the HS group did not substantially improve.
Copyright restrictions may apply
Results
Outcomes 1 Hour After Saline Administration
•
•
•
•
Copyright restrictions may apply
Difference in RACS at 1
hour after treatment
demonstrated
significantly less
improvement in HS group
compared with NS group.
No significant difference
in RDAI score.
Greater decrease in
respiratory rate from
baseline to 1 hour in NS
group compared with HS
group.
No significant differences
in secondary outcomes.
Results
•
No significant difference in RACS at 2 hours after study intervention
between the 2 groups.
•
During patient follow-up, there were no significant differences between the
HS and NS groups in:
– Parental perception of study treatment improving their child’s symptoms.
– Unscheduled pediatrician visits.
– Hospitalization after initially being discharged from the ED.
•
No adverse events occurred during the study.
Copyright restrictions may apply
Comment
•
This randomized clinical trial demonstrated that infants with bronchiolitis
with persistent distress after nasal suctioning and a trial of albuterol who
received a single dose of nebulized 3% HS in the ED had less improvement
in respiratory distress compared with those receiving NS.
•
Lack of benefit of HS compared with NS in the ED is consistent with findings
of prior studies.
•
These results are in contrast to those of studies examining the use of HS
repeatedly over time, which generally show a decreased length of stay in
hospitalized infants or improved clinical severity in outpatients.
Copyright restrictions may apply
Comment
•
Limitations
– Single-center study—results may not be generalizable.
– Single dose of 3% HS—relatively low concentration of HS. Results may differ with
increasing concentrations or repeated doses.
– Intended to separate delivery of albuterol and HS, so primary outcome was
measured after peak effect of albuterol; however, it is possible there were residual
effects of albuterol at time of assessment.
– RACS as short-term outcome; however, ED and primary care providers make
disposition and treatment decisions based on short-term outcomes, making this a
relevant choice given the practice environment.
•
Conclusions
– HS results in less improvement 1 hour after treatment in the ED compared with NS in
infants with bronchiolitis who had persistent distress after albuterol and nasal
suctioning.
– Administration of a single dose of HS in the acute care setting does not appear to be
more effective than NS in improving short-term respiratory distress in bronchiolitis.
Copyright restrictions may apply
Contact Information
•
If you have questions, please contact the corresponding author:
– Todd A. Florin, MD, MSCE, Division of Pediatric Emergency
Medicine, Cincinnati Children’s Hospital Medical Center, 3333 Burnet
Ave, ML 2008, Cincinnati, OH 45229 ([email protected]).
Funding/Support
•
This study was supported by a Young Investigator Award from the
Academic Pediatric Association.
Conflict of Interest Disclosures
•
None reported.
Copyright restrictions may apply