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

NCT ID: NCT02538458

Last Updated: 2017-11-06

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-03-31

Brief Summary

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

Detailed Description

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In acute bronchiolitis in infants, 3% hypertonic saline nebulizations proved to be efficient, reducing the hospitalization length and clinical severity scores. Among the questions remaining, treatment length is still being discussed in the literature. The trial hypothesis is that the efficiency of a 24 hours treatment by 3% hypertonic saline is not inferior to a 72 hours treatment, in acute bronchiolitis in infants. The primary objective of the study is to compare the efficiency of a 24 hours treatment by 3 % hypertonic saline, versus a 72 hours treatment maximum, on clinical remission, judged by the Wang score measured 72 hours after starting treatment, in children younger than 12 month hospitalized for acute bronchiolitis.

Conditions

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Bronchiolitis

Keywords

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Saline Solution, Hypertonic (3 %) Infant

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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Test group

3 % hypertonic saline up to 72H.

Group Type ACTIVE_COMPARATOR

3 % hypertonic saline up to 72H

Intervention Type DRUG

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

Placebo control group

* 3 % hypertonic saline up to 24H.
* Followed by 48 hours of placebo (nebulized 0.9% normal saline).

Group Type PLACEBO_COMPARATOR

3 % hypertonic saline up to 24H

Intervention Type DRUG

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

Interventions

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3 % hypertonic saline up to 72H

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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3 % hypertonic saline palcebo

Eligibility Criteria

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Inclusion Criteria

* 1st or 2nd episode of acute bronchiolitis, defined by respiratory symptoms episode with initial rhinitis, then cough, then one of the following symptoms : wheezing, crackling, respiratory distress
* Winter epidemic period from November, the 15th, to March the 15th
* Age \< 12 months
* Admission Wang score included between 4 and 8
* Infant hospitalized for gravity clinical criteria of severity
* Nebulized 3 % hypertonic saline treatment since less than 24 hours
* Infant with social security card coverage
* Free consent of at least one of the parental authority holder

Exclusion Criteria

* Pulmonary, cardiac or neurologic chronic underlying disease
* Prematurity \< 32 GW
* Asthma (3rd episode or more)
* Admission oxygen saturation level \< 85 %, Wang score ≥ 9
Minimum Eligible Age

1 Minute

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AGIR à Dom

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine BARBIER, PHD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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Hôpital Couple Enfant

Grenoble, , France

Site Status

Countries

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France

References

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Beal G, Barbier C, Thoret S, Rubio A, Bonnet M, Mazet R, Ego A, Pin I. Nebulized hypertonic saline 3% for 1 versus 3 days in hospitalized bronchiolitis: a blinded non-inferiority randomized controlled trial. BMC Pediatr. 2019 Nov 8;19(1):417. doi: 10.1186/s12887-019-1804-0.

Reference Type DERIVED
PMID: 31699072 (View on PubMed)

Other Identifiers

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2014-A01335-42

Identifier Type: -

Identifier Source: org_study_id