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Nasal Irrigation in Infants With Bronchiolitis.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ronfani Luca, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier:
NCT02162745
First received: June 11, 2014
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Bronchiolitis Drug: Isotonic solution (NaCl 0.9%) Drug: Hypertonic solution (NaCl 3%) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Evaluate the Efficacy of Nasal Irrigation in Infants With Bronchiolitis

Further study details as provided by Ronfani Luca, IRCCS Burlo Garofolo:

Primary Outcome Measures:
  • Oxygen saturation (%) [ Time Frame: up to 50 minutes after allocation ]
    Measurement of arterial oxygen saturation (SpO2) of hemoglobin with digital pulse oximeter


Secondary Outcome Measures:
  • 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).


Enrollment: 133
Study Start Date: October 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 365 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02162745

Locations
Italy
Pediatria, Azienda Ospedaliera Santa Maria Degli Angeli
Pordenone, Friuli Venezia Giulia, Italy, 33170
Emergency Department, IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, Italy, 34137
Sponsors and Collaborators
IRCCS Burlo Garofolo
Investigators
Study Chair: Dino Barbi, MD IRCCS Burlo Garofolo, Trieste, Italy
Study Director: Silvana Schreiber, RN IRCCS Burlo Garofolo, Trieste, Italy
  More Information

Responsible Party: Ronfani Luca, MD, PhD, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT02162745     History of Changes
Other Study ID Numbers: RC 35/12
Study First Received: June 11, 2014
Last Updated: June 12, 2014

Keywords provided by Ronfani Luca, IRCCS Burlo Garofolo:
Bronchiolitis
Normal saline solution
Hypertonic solution
Nasal irrigation

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on June 23, 2017