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Hypertonic Saline for Outpatient Bronchiolitis

NCT ID: NCT00696540

Last Updated: 2008-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-10-31

Brief Summary

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We will study if small children who become ill with respiratory distress during the RSV epidemic are better relieved with salbutamol nebulizations diluted in hypertonic (3%), instead of normal (0.9%) saline.

Detailed Description

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In Santiago, Chile, a near collapse of health services is a notorious feature of every winter when vast numbers of small children line for attention because of respiratory distress caused by a probable RSV infection.

Our study will examine if nebulized salbutamol diluted in hypertonic (3%), instead of normal (0.9%) saline, provides better relief in outpatients.

If hypertonic saline proves safe and effective, the patients could be better managed and the pressure for attention diminished at a low cost, by a simple change in the saline ampule.

Conditions

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Bronchiolitis Respiratory Distress

Keywords

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Bronchiolitis, respiratory distress, hypertonic saline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Salbutamol is diluted in hypertonic (3%) saline.

Group Type EXPERIMENTAL

Inhalation of salbutamol diluted in hypertonic saline

Intervention Type DRUG

The first of 3 nebulizations of 0.5 mg of Salbutamol is diluted in 3.5 ml of hypertonic (3%) saline. The second and the third are diluted in normal (0.9%) saline.

2

Salbutamol is diluted in normal (0.9%) saline.

Group Type ACTIVE_COMPARATOR

Inhalation of salbutamol diluted in normal saline

Intervention Type DRUG

The 3 nebulizations of 0.5 mg of Salbutamol are diluted in 3.5 ml of normal (0.9%) saline.

Interventions

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Inhalation of salbutamol diluted in hypertonic saline

The first of 3 nebulizations of 0.5 mg of Salbutamol is diluted in 3.5 ml of hypertonic (3%) saline. The second and the third are diluted in normal (0.9%) saline.

Intervention Type DRUG

Inhalation of salbutamol diluted in normal saline

The 3 nebulizations of 0.5 mg of Salbutamol are diluted in 3.5 ml of normal (0.9%) saline.

Intervention Type DRUG

Other Intervention Names

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Albuterol diluted in hypertonic saline Albuterol diluted in normal saline

Eligibility Criteria

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Inclusion Criteria

1. Age 1 to 24 months
2. Mild to moderate respiratory distress (Tal score below 9)
3. Up to 5 days of respiratory symptoms, including today
4. Expiratory wheezing heard on chest auscultation
5. Indication of salbutamol nebulization treatment by attending physician

Exclusion Criteria

1. Two prior episodes of wheezing
2. Premature birth (below 38 weeks), if below 6 months of age
3. Lobar pneumonia
4. Body temperature above 38 degree Celsius
5. Use of salbutamol during the previous 6 hours
6. Pulse oxymetry reading below 90%
7. Congenital heart disease
8. Chronic pulmonary disease: Asthma, cystic fibrosis, bronchopulmonary dysplasia
9. Other chronic or genetic condition or disease
Minimum Eligible Age

1 Month

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clínica Vespucio, Santiago, Chile

UNKNOWN

Sponsor Role collaborator

University Diego Portales

OTHER

Sponsor Role lead

Responsible Party

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Facultad de Ciencias de la Salud, Universidad Diego Portales, Santiago. Chile

Principal Investigators

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Irmeli Roine, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Diego Portales

Ricardo Mercado, MD

Role: STUDY_DIRECTOR

Clinica Vespucio, Santiago, Chile

Locations

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Clínica Vespucio

Santiago, , Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Irmeli Roine, MD, PhD

Role: CONTACT

Phone: +56-2-6762916

Email: [email protected]

Ricardo Mercado, MD

Role: CONTACT

Phone: +56-9-3320792

Email: [email protected]

Facility Contacts

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Ricardo Mercado, MD

Role: primary

Patricio Olivares, MD

Role: backup

References

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Sarrell EM, Tal G, Witzling M, Someck E, Houri S, Cohen HA, Mandelberg A. Nebulized 3% hypertonic saline solution treatment in ambulatory children with viral bronchiolitis decreases symptoms. Chest. 2002 Dec;122(6):2015-20. doi: 10.1378/chest.122.6.2015.

Reference Type BACKGROUND
PMID: 12475841 (View on PubMed)

Mandelberg A, Tal G, Witzling M, Someck E, Houri S, Balin A, Priel IE. Nebulized 3% hypertonic saline solution treatment in hospitalized infants with viral bronchiolitis. Chest. 2003 Feb;123(2):481-7. doi: 10.1378/chest.123.2.481.

Reference Type BACKGROUND
PMID: 12576370 (View on PubMed)

Other Identifiers

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UDP-CT1-08

Identifier Type: -

Identifier Source: org_study_id