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Efficacy and Safety of 3% Hypertonic Saline Inhalation (24h vs 72h) to Treat Acute Bronchiolitis in Hospitalized Infants

NCT02538458 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-11-06

No results posted yet for this study

Summary

Efficacy/Safety of 3% hypertonic saline inhalation (24H vs 72H) to treat acute bronchiolitis in infants.

Conditions

  • Bronchiolitis

Interventions

DRUG

3 % hypertonic saline up to 72H

Treatment by inhalation of 3 % hypertonic saline, up to 72H. Test group.

DRUG

3 % hypertonic saline up to 24H

* Treatment by inhalation of 3 % hypertonic saline, up to 24H. * followed by 48h of placebo : isotonic saline inhalation. Placebo control group.

Sponsors & Collaborators

  • AGIR à Dom

    collaborator OTHER

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Catherine BARBIER, PHD · University Hospital, Grenoble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02538458 on ClinicalTrials.gov