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

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 4

Conditions: Bronchiolitis

Treatments: Drug: 3 % hypertonic saline up to 24H; Drug: 3 % hypertonic saline up to 72H

Study type: Interventional

Funder types: Other

Identifiers

NCT02538458

2014-A01335-42

Details and patient eligibility

About

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

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 1 minute to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Test group

Active Comparator group

Description:

3 % hypertonic saline up to 72H.

Treatment:

Drug: 3 % hypertonic saline up to 72H

Placebo control group

Placebo Comparator group

Description:

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

Treatment:

Drug: 3 % hypertonic saline up to 24H