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NCT01488448
A Double-Blind, Controlled, Randomized Clinical Trial of Nebulized Hypertonic Saline for Hospitalized Infants With Viral Bronchiolitis
NA trial testing 3% sodium chloride in Bronchiolitis in 227 participants. Completed in 1 August 2015.
1 July 2014
Quick facts
| Lead sponsor | Montefiore Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 227 |
| Start date | 1 November 2011 |
| Primary completion | 1 July 2014 |
| Estimated completion | 1 August 2015 |
| Sites | 1 location across United States |
Drugs / interventions tested
- 3% sodium chloride — full drug profile →
- 0.9% sodium chloride
Conditions studied
- Bronchiolitis — all drugs for Bronchiolitis →
Sponsor
Montefiore Medical Center
Who can join
Under 12 Months, any sex, with Bronchiolitis. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Length of Stay in the Study-LOS--Intention to Treat Analysis
Time frame: Time of first study treatment until time of discharge
Length of stay will be defined by the duration between the time of first study treatment 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. -
Length of Stay in the Study-LOS by Per Protocol Analysis
Time frame: Time of first study treatment until time of discharge
Length of stay will be defined by the duration between the time of first study treatment 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.
Sponsor's own description
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Nebulised hypertonic saline solution for acute bronchiolitis in infants.
Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. · · 2017 · cited 48× · PMID 29265171 · DOI 10.1002/14651858.cd006458.pub4
Verify or expand the search:
- PubMed search for NCT01488448
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Bronchiolitis
Currently open trials in the same condition.
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- NCT06862895 — Effect of Chest Physiotherapy on Clinical Outcome of Infants With Bronchiolitis · NA · recruiting
- NCT06842238 — Descriptive Study of the Initial Management of Young Children With Moderate Acute BRONCHiotitis With Home Hospitalisatio · recruiting
- NCT06425107 — Point-of-Care Lung Ultrasound for Prognosis in Critically Ill Infants With Acute Lower Respiratory Tract Infection · recruiting
- NCT06108648 — Efficacy of Lavender Essential Oil Chest Wraps in Infants With Bronchiolitis · Phase 4 · recruiting
Other Montefiore Medical Center trials
Trials by the same sponsor.
- NCT07224061 — Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools · NA · not yet recruiting
- NCT06775886 — Effect of Personalized Accelerated Pacing in Symptomatic Patients With Non-Obstructive Hypertrophic Cardiomyopathy · NA · terminated
- NCT06919094 — A Virtual Life Story Club Intervention to Improve Loneliness and Apathy in Community-Dwelling Older Adults · NA · recruiting
- NCT07076069 — The Effect of Multimodal Pain Regimen on Use of Narcotics After Rotator Cuff Tear Repair · Phase 4 · recruiting
- NCT07037940 — Physician Response Evaluation With Contextual Insights vs. Standard Engines - Artificial Intelligence RAG vs LLM Clinica · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01488448 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Montefiore Medical Center
- Last refreshed: 31 January 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01488448.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing