A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis
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Purpose
The purpose of this study is to determine if nebulized hypertonic saline (or extra salty water mist) helps infants less than 12 months old hospitalized with bronchiolitis (or bad chest colds) get better enough to be discharged from the hospital sooner than those infants given nebulized normal saline (or regular salty water mist).
| Condition | Intervention |
|---|---|
|
Bronchiolitis |
Drug: 3% sodium chloride Drug: 0.9% sodium chloride |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Controlled, Randomized Clinical Trial of Nebulized Hypertonic Saline for Hospitalized Infants With Viral Bronchiolitis |
- Length of Hospital Stay [ Time Frame: duration of hospitalization, average 2-3 days, with additional follow-up phone call 1 week after discharge ] [ Designated as safety issue: No ]Length of stay will be defined by the duration between the time of decision to admit a patient (from the time a bed is requested) to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used.
- Readmission for bronchiolitis within 30 days of discharge [ Time Frame: within 30 days of hospital discharge ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 232 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Nebulized Hypertonic Saline |
Drug: 3% sodium chloride
4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge
Other Names:
|
| Placebo Comparator: Nebulized Normal Saline |
Drug: 0.9% sodium chloride
4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge
Other Names:
|
Detailed Description:
Bronchiolitis is a common admitting diagnosis for children less than 1 year of age. Although bronchiolitis has a high prevalence, there is a lack of a unified inpatient treatment plan beyond supportive care of supplemental oxygen and intravenous hydration. There have been many different approaches to the treatment of bronchiolitis, but none have conclusively proven to be beneficial. Several early studies show promise for the use of nebulized hypertonic saline, however the majority of these studies are done outside the United States and with adjunctive therapy. To date, the data suggesting that nebulized hypertonic saline is safe and effective for reducing length of stay in bronchiolitis is strong but not generalizable for the United States. The objective of this study is to conduct the first double-blind, randomized controlled trial in the United States of nebulized hypertonic saline without adjunctive therapy, including infants with bronchiolitis, including those with prior history of wheeze, to assess the effect on length of stay and therefore resource utilization.
Eligibility| Ages Eligible for Study: | up to 12 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patients 0-12 months of age admitted to the hospital with a diagnosis of bronchiolitis.
Exclusion Criteria:
- status asthmaticus
- chronic cardiopulmonary disease
- Trisomy 21
- immunodeficiency or transplant recipient
- neuromuscular disease
- admission directly to the intensive care unit
- previous use of nebulized hypertonic saline less than 12 hours prior to presentation
- previous enrollment in the study in the 72 hours prior to presentation
Contacts and Locations| Contact: Alyssa H Silver, MD | 718-741-2304 | alysilve@montefiore.org |
| Contact: Katherine M O'Connor, MD | 718-741-2281 | koconnor@montefiore.org |
| United States, New York | |
| Children's Hospital at Montefiore | Recruiting |
| Bronx, New York, United States, 10467 | |
| Contact: Alyssa H Silver, MD 718-741-2304 alysilve@montefiore.org | |
| Contact: Katherine M O'Connor, MD 718-741-2281 koconnor@montefiore.org | |
| Principal Investigator: Alyssa H Silver, MD | |
| Sub-Investigator: Katherine M O'Connor, MD | |
| Sub-Investigator: Gabriella C Azzarone, MD | |
| Sub-Investigator: Nora Esteban-Cruciani, MD, MS | |
| Sub-Investigator: Lindsey Douglas, MD | |
| Sub-Investigator: Sheila Liewehr, MD | |
| Sub-Investigator: Joanne Nazif, MD | |
| Sub-Investigator: Helen Rhim, MD | |
| Sub-Investigator: Diana Lee, MD | |
| Sub-Investigator: Courtney McNamara, MD | |
| Sub-Investigator: Susan Villegas, PhD | |
| Sub-Investigator: Ilir Agalliu, MD, ScD | |
| Principal Investigator: | Alyssa H Silver, MD | Albert Einstein College of Medicine of Yeshiva University |
More Information
No publications provided
| Responsible Party: | Alyssa Silver, Attending Physician, Pediatric Hospitalist, Assistant Professor of Pediatrics, Montefiore Medical Center |
| ClinicalTrials.gov Identifier: | NCT01488448 History of Changes |
| Other Study ID Numbers: | 11-09-329 |
| Study First Received: | December 2, 2011 |
| Last Updated: | March 27, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Montefiore Medical Center:
|
Hypertonic saline Bronchiolitis Infants |
Wheezing Nebulized Bronchodilator |
Additional relevant MeSH terms:
|
Bronchiolitis Bronchiolitis, Viral Bronchitis Bronchial Diseases Respiratory Tract Diseases |
Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 21, 2013