NCT02538458

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

1.3 years

First QC Date

August 5, 2015

Last Update Submit

November 2, 2017

Conditions

Bronchiolitis

Keywords

Saline Solution, Hypertonic (3 %)Infant

Outcome Measures

Primary Outcomes (1)

  • Wang score after 72 hours of treatment

    72 hours

Secondary Outcomes (6)

  • Recovery time

    From Day 1 to end of the hospitalisation within 2 weeks, assessed at EOS (End of study for the patient, meaning discharge from hospital)

  • To determine percentage of patient needing transfer to the PICU or use of mechanical ventilation

    From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)

  • To assess average time of Oxygen therapy

    From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)

  • To assess average time of Tube feeding

    From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)

  • To determine variation of Wang score during hospitalisation

    measured at Day 1, 2, 3, 4 and day of discharge.

  • +1 more secondary outcomes

Study Arms (2)

Test group

ACTIVE COMPARATOR

3 % hypertonic saline up to 72H.

Drug: 3 % hypertonic saline up to 72H

Placebo control group

PLACEBO COMPARATOR

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

Drug: 3 % hypertonic saline up to 24H

Interventions

3 % hypertonic saline up to 72HDRUG

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

Also known as: 3 % hypertonic saline
Test group
3 % hypertonic saline up to 24HDRUG

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

Also known as: palcebo
Placebo control group

Eligibility Criteria

Age1 Minute - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • st 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Couple Enfant

Grenoble, 38043, France

Location

Related Publications (1)

  • 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.

    PMID: 31699072DERIVED

MeSH Terms

Conditions

Bronchiolitis

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Catherine BARBIER, PHD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2015

First Posted

September 2, 2015

Study Start

November 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

FR(1)