Efficacy of Nebulized Hypertonic Saline in the Treatment of Acute Bronchiolitis

NCT ID: NCT01238848

Last Updated: 2017-02-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this study is to evaluate the efficacy of hypertonic saline vs. normal saline in the treatment of infants hospitalized for bronchiolitis, regarding length of hospital stay, oxygen requirements and clinical outcome.

Detailed Description

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Despite bronchiolitis is a very frequent disease among infants, there are still controversies regarding its treatment. Hypertonic saline has been proposed as useful treatment in these children, bur information is still controversial.

The aim is to asses that using Nebulized Hypertonic Saline with bronchodilators (albuterol) may reduce the days of hospitalization and improve clinical outcomes in patients with acute bronchiolitis, compared with using Normal Saline with albuterol.

Conditions

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Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypertonic

Nebulized hypertonic saline (sodium chloride 3%) + albuterol

Group Type EXPERIMENTAL

Hypertonic saline

Intervention Type DRUG

3 cc nebulized hypertonic saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days

Normal

Normal saline (sodium chloride 0.9%) + albuterol

Group Type ACTIVE_COMPARATOR

Normal saline

Intervention Type DRUG

3 cc nebulized normal saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days

Interventions

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Hypertonic saline

3 cc nebulized hypertonic saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days

Intervention Type DRUG

Normal saline

3 cc nebulized normal saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days

Intervention Type DRUG

Other Intervention Names

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ClNa 3% (sodium chloride 3%) ClNa 0.9% (sodium chloride 0.9%)

Eligibility Criteria

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Inclusion Criteria

* Infants aged 1 to 24 months, hospitalized for first episode of bronchiolitis, with severity score ≥ 5 points and oxygen saturation ≥ 97%.

Exclusion Criteria

* Chronic respiratory or cardiovascular disease, respiratory failure.
Minimum Eligible Age

1 Month

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General de Niños Pedro de Elizalde

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria I Espelt, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital General de Niños Pedro de Elizalde

Locations

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Hospital General de Niños Pedro de Elizalde

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Countries

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Argentina

References

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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.

Reference Type BACKGROUND
PMID: 18843717 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20713480 (View on PubMed)

Zhang L, Mendoza-Sassi RA, Wainwright CE, Aregbesola A, Klassen TP. Nebulised hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2023 Apr 4;4(4):CD006458. doi: 10.1002/14651858.CD006458.pub5.

Reference Type DERIVED
PMID: 37014057 (View on PubMed)

Other Identifiers

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HGNPE-14-2010

Identifier Type: -

Identifier Source: org_study_id

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