Nasal Irrigation in Infants With Bronchiolitis.

June 12, 2014 updated by: Ronfani Luca, IRCCS Burlo Garofolo

Randomized Controlled Trial to Evaluate the Efficacy of Nasal Irrigation in Infants With Bronchiolitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Friuli Venezia Giulia
      • Pordenone, Friuli Venezia Giulia, Italy, 33170
        • Pediatria, Azienda Ospedaliera Santa Maria Degli Angeli
      • Trieste, Friuli Venezia Giulia, Italy, 34137
        • Emergency Department, IRCCS Burlo Garofolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Isotonic solution (NaCl 0.9%)
Single nasal irrigation with 1 ml of isotonic solution (NaCl 0.9%) per each nostril
Drug: Isotonic solution (NaCl 0.9%)
Experimental: Hypertonic solution (NaCl 3%)
Single nasal irrigation with 1 ml of hypertonic solution (NaCl 3%) per each nostril
Drug: Hypertonic solution (NaCl 3%)
No Intervention: Supportive care
Wiping the nose, positioning the child, changing a wet diaper, feeding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen saturation (%)
Time Frame: up to 50 minutes after allocation
Measurement of arterial oxygen saturation (SpO2) of hemoglobin with digital pulse oximeter
up to 50 minutes after allocation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory effort (WARME score)
Time Frame: 5, 15, 20, 50 minutes after allocation
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).
5, 15, 20, 50 minutes after allocation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Burlo Garofolo

Investigators

  • Study Director: Silvana Schreiber, RN, IRCCS Burlo Garofolo, Trieste, Italy
  • Study Chair: Dino Barbi, MD, IRCCS Burlo Garofolo, Trieste, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

June 11, 2014

First Submitted That Met QC Criteria

June 12, 2014

First Posted (Estimate)

June 13, 2014

Study Record Updates

Last Update Posted (Estimate)

June 13, 2014

Last Update Submitted That Met QC Criteria

June 12, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC 35/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bronchiolitis

Clinical Trials on Isotonic solution (NaCl 0.9%)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe