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Nasal Irrigation in Infants With Bronchiolitis.

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Isotonic solution (NaCl 0.9%)
Hypertonic solution (NaCl 3%)
Sponsored by
IRCCS Burlo Garofolo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Bronchiolitis, Normal saline solution, Hypertonic solution, Nasal irrigation

Eligibility Criteria

1 Day - 365 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • infants <1 year
  • diagnosis of bronchiolitis with respiratory distress, rhinitis, cough
  • oxygen saturation between 88 and 94%

Exclusion Criteria:

  • previous treatments (nasal irrigation or suctioning, oxygen, nebulized drugs, nebulized hypertonic solution, antipyretics up to 6 hours before the study entry, oral steroids at any time before study entry)
  • chronic illness

Sites / Locations

  • Pediatria, Azienda Ospedaliera Santa Maria Degli Angeli
  • Emergency Department, IRCCS Burlo Garofolo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Isotonic solution (NaCl 0.9%)

Hypertonic solution (NaCl 3%)

Supportive care

Arm Description

Single nasal irrigation with 1 ml of isotonic solution (NaCl 0.9%) per each nostril

Single nasal irrigation with 1 ml of hypertonic solution (NaCl 3%) per each nostril

Wiping the nose, positioning the child, changing a wet diaper, feeding.

Outcomes

Primary Outcome Measures

Oxygen saturation (%)
Measurement of arterial oxygen saturation (SpO2) of hemoglobin with digital pulse oximeter

Secondary Outcome Measures

Respiratory effort (WARME score)
Evaluation of the respiratory effort using the validated WARME score (evaluation of: 1) respiratory rate; 2) prolonged expiration; 2) wheezing; 3) air exchange; 4) muscle use).

Full Information

First Posted
June 11, 2014
Last Updated
June 12, 2014
Sponsor
IRCCS Burlo Garofolo
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1. Study Identification

Unique Protocol Identification Number
NCT02162745
Brief Title
Nasal Irrigation in Infants With Bronchiolitis.
Official Title
Randomized Controlled Trial to Evaluate the Efficacy of Nasal Irrigation in Infants With Bronchiolitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Burlo Garofolo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Bronchiolitis is a leading cause of acute illness and hospitalization in the first year of life. Most children with bronchiolitis have mild disease and are managed at home with support from primary care providers, while children with more severe symptoms require supportive therapy with oxygen and fluid administration. Neonates may be obligate nasal breathers until they are at least 2 months old and nasal obstruction may play a relevant role in respiratory resistances throughout the first months of life, whereas nasal passages may exhibit as much as 50% of the total airway resistance. Some guidelines recommend to clear the nostrils of secretions to improve airway patency but no controlled trial on the efficacy of nasal irrigation in infants with bronchiolitis was carried out. The aim of this randomized controlled trial is to compare normal saline and hypertonic solution for nasal irrigation versus simple supportive care in infants admitted to Emergency Department with bronchiolitis and mild desaturation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Bronchiolitis, Normal saline solution, Hypertonic solution, Nasal irrigation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isotonic solution (NaCl 0.9%)
Arm Type
Experimental
Arm Description
Single nasal irrigation with 1 ml of isotonic solution (NaCl 0.9%) per each nostril
Arm Title
Hypertonic solution (NaCl 3%)
Arm Type
Experimental
Arm Description
Single nasal irrigation with 1 ml of hypertonic solution (NaCl 3%) per each nostril
Arm Title
Supportive care
Arm Type
No Intervention
Arm Description
Wiping the nose, positioning the child, changing a wet diaper, feeding.
Intervention Type
Drug
Intervention Name(s)
Isotonic solution (NaCl 0.9%)
Intervention Type
Drug
Intervention Name(s)
Hypertonic solution (NaCl 3%)
Primary Outcome Measure Information:
Title
Oxygen saturation (%)
Description
Measurement of arterial oxygen saturation (SpO2) of hemoglobin with digital pulse oximeter
Time Frame
up to 50 minutes after allocation
Secondary Outcome Measure Information:
Title
Respiratory effort (WARME score)
Description
Evaluation of the respiratory effort using the validated WARME score (evaluation of: 1) respiratory rate; 2) prolonged expiration; 2) wheezing; 3) air exchange; 4) muscle use).
Time Frame
5, 15, 20, 50 minutes after allocation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
365 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: infants <1 year diagnosis of bronchiolitis with respiratory distress, rhinitis, cough oxygen saturation between 88 and 94% Exclusion Criteria: previous treatments (nasal irrigation or suctioning, oxygen, nebulized drugs, nebulized hypertonic solution, antipyretics up to 6 hours before the study entry, oral steroids at any time before study entry) chronic illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dino Barbi, MD
Organizational Affiliation
IRCCS Burlo Garofolo, Trieste, Italy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Silvana Schreiber, RN
Organizational Affiliation
IRCCS Burlo Garofolo, Trieste, Italy
Official's Role
Study Director
Facility Information:
Facility Name
Pediatria, Azienda Ospedaliera Santa Maria Degli Angeli
City
Pordenone
State/Province
Friuli Venezia Giulia
ZIP/Postal Code
33170
Country
Italy
Facility Name
Emergency Department, IRCCS Burlo Garofolo
City
Trieste
State/Province
Friuli Venezia Giulia
ZIP/Postal Code
34137
Country
Italy

12. IPD Sharing Statement

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Nasal Irrigation in Infants With Bronchiolitis.

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