NCT00696540

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

June 12, 2008

Status Verified

June 1, 2008

Enrollment Period

3 months

First QC Date

June 9, 2008

Last Update Submit

June 9, 2008

Conditions

BronchiolitisRespiratory Distress

Keywords

Bronchiolitis, respiratory distress, hypertonic saline

Outcome Measures

Primary Outcomes (1)

  • Change in the respiratory distress score (Tal) between the basal score and the final score after 3 salbutamol nebulizations

    1 hour

Secondary Outcomes (4)

  • Change in the respiratory distress score (Tal) between the basal score and the first nebulization

    15 to 20 minutes

  • Change in the respiratory distress score (Tal) between the basal score and the second nebulization

    15 to 20 minutes after the first nebulization

  • Change in pulse oxymetry reading between the basal score and after each of the three nebulizations

    1 hour

  • Change in cardiac frequency, irritability, general condition or anything else between the basal score and the first, second and third nebulization

    1 hour

Study Arms (2)

1

EXPERIMENTAL

Salbutamol is diluted in hypertonic (3%) saline.

Drug: Inhalation of salbutamol diluted in hypertonic saline

2

ACTIVE COMPARATOR

Salbutamol is diluted in normal (0.9%) saline.

Drug: Inhalation of salbutamol diluted in normal saline

Interventions

Inhalation of salbutamol diluted in hypertonic salineDRUG

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.

Also known as: Albuterol diluted in hypertonic saline
1
Inhalation of salbutamol diluted in normal salineDRUG

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

Also known as: Albuterol diluted in normal saline
2

Eligibility Criteria

Age1 Month - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Two prior episodes of wheezing
  • Premature birth (below 38 weeks), if below 6 months of age
  • Lobar pneumonia
  • Body temperature above 38 degree Celsius
  • Use of salbutamol during the previous 6 hours
  • Pulse oxymetry reading below 90%
  • Congenital heart disease
  • Chronic pulmonary disease: Asthma, cystic fibrosis, bronchopulmonary dysplasia
  • Other chronic or genetic condition or disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Vespucio

Santiago, 00300, Chile

RECRUITING

Related Publications (2)

  • 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.

    PMID: 12475841BACKGROUND

  • 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.

    PMID: 12576370BACKGROUND

MeSH Terms

Conditions

BronchiolitisDyspnea

Interventions

Saline Solution, HypertonicSaline Solution

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical PreparationsCrystalloid SolutionsIsotonic Solutions

Study Officials

  • Irmeli Roine, MD, PhD

    University Diego Portales

    PRINCIPAL INVESTIGATOR

  • Ricardo Mercado, MD

    Clinica Vespucio, Santiago, Chile

    STUDY DIRECTOR

Central Study Contacts

Irmeli Roine, MD, PhD

CONTACT

+56-2-6762916irmeli.roine@prof.udp.cl

Ricardo Mercado, MD

CONTACT

+56-9-3320792rmercado@ssmso.cl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2008

First Posted

June 12, 2008

Study Start

June 1, 2008

Primary Completion

September 1, 2008

Study Completion

October 1, 2008

Last Updated

June 12, 2008

Record last verified: 2008-06

Locations

CL(1)