Evidence map›Paper›PMID 31699072›Full record

Trial reportBMC pediatrics2019

Nebulized hypertonic saline 3% for 1 versus 3 days in hospitalized bronchiolitis: a blinded non-inferiority randomized controlled trial.

Gaëlle Beal, Catherine Barbier, Sophie Thoret, Amandine Rubio, Mathilde Bonnet, Roseline Mazet, Anne Ego, Isabelle Pin

Registry-linked trialOpen access · goldAbstract readEquivalence TrialRandomized Controlled Trial
In one paragraph

Trial report in BMC pediatrics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02538458 (Effects of Reduction of the Length of Treatment by Nebulized 3% Hypertonic Saline From 72 to 24 Hours on Clinical Remission, in Children Younger Than 12 Month Hospitalized for Acute Bronchiolitis. BRONDUSAL), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02538458 phase4completednot on this map

Effects of Reduction of the Length of Treatment by Nebulized 3% Hypertonic Saline From 72 to 24 Hours on Clinical Remission, in Children Younger Than 12 Month Hospitalized for Acute Bronchiolitis. BRONDUSAL

TypeinterventionalSponsorUniversity Hospital, GrenobleRan2014 to 2016Enrolled120ConditionsBronchiolitisArms3 % hypertonic saline up to 72H, 3 % hypertonic saline up to 24H
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 8 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 1 country.

Gaëlle BealDepartment of Pediatrics, Centre Hospitalier Métropole Savoie, FR-73000, Chambéry, France.
Catherine BarbierDepartment of Pediatrics, Centre Hospitalier Universitaire Grenoble Alpes, FR-38000, Grenoble, France.
Sophie ThoretCIC U1406, INSERM, FR-38000, Grenoble, France.
Amandine RubioDepartment of Pediatrics, Centre Hospitalier Universitaire Grenoble Alpes, FR-38000, Grenoble, France.
Mathilde BonnetDepartment of Pediatrics, Centre Hospitalier Universitaire Grenoble Alpes, FR-38000, Grenoble, France.
Roseline MazetDepartment of Pharmacy, CHU Grenoble Alpes, FR-38000, Grenoble, France.
Anne EgoCIC U1406, INSERM, FR-38000, Grenoble, France.
Isabelle PinDepartment of Pediatrics, Centre Hospitalier Universitaire Grenoble Alpes, FR-38000, Grenoble, France. ipin@chu-grenoble.fr.ORCID 0000-0002-7529-6999
Centre Hospitalier Universitaire de Grenoble · FRInserm · FRCentre Hospitalier Métropole Savoie · FRInstitut polytechnique de Grenoble · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe use and optimal duration of treatment with nebulized hypertonic saline (HS) in infants hospitalized for acute bronchiolitis is unclear. The objective was to compare the efficacy of 1 versus 3 days of nebulized 3% HS at 72 h of treatment. We conducted a blinded non-inferiority randomized controlled trial including infants aged less than 12 months old, hospitalized for a moderate bronchiolitis.

methodsNebulisations of 3% HS for 1 day were followed by either the continuation of 3% HS (HS3d group) or switched to 0.9% normal isotonic saline (HS1d group) for 2 days Randomization was performed according to a predefined list with a 1:1 ratio, obtained with a random generator number with blocks.. Main outcome was mean Wang clinical severity score (CSS) after 72 h of treatment.

resultsOne hundred sixteen infants (HS1d n = 59 and HS3d n = 57), were included over two epidemic seasons from 2014 to 2016, but recruitement did not reach the planned sample size. The difference for the Wang CSS score in the HS3d vs HS1d group was 0.71 [IC 90% 0.1; 1.3], above the precluded value of 0.4 set in the protocol defining the non-inferiority of shorter treatment duration. Clinical remission was more rapidly obtained in the HS3d than in HS1d (2.3 ± 1.6 vs 2.9 ± 1.4 days, p = 0.04), with a non-significant tendency for less need of nutritional support and supplemental oxygen in HS3d group. Clinical worsening and treatment intolerance were similar in the 2 groups.

conclusionsDespite being underpowered, results seem not to be in favour of reducing the duration of nebulised HS treatment from 3 to 1 day in acute moderate bronchiolitis.

trial registrationClinical trials NCT02538458, October 2014.

Indexed as

Acute DiseaseBronchiolitisChild, HospitalizedDouble-Blind MethodDrug Administration ScheduleFemaleHumansInfantMaleNebulizers and VaporizersNutritional SupportOxygenProspective StudiesRemission InductionSaline SolutionSaline Solution, HypertonicOxygenSaline SolutionSaline Solution, HypertonicBronchiolitisChildrenHypertonic saline

Identifiers

PMID31699072
PMCPMC6839239
OpenAlexW2989494549

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.