Nasal Irrigation in Infants With Bronchiolitis.

Overview

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.

Full Title of Study: “Randomized Controlled Trial to Evaluate the Efficacy of Nasal Irrigation in Infants With Bronchiolitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: May 2014

Interventions

  • Drug: Isotonic solution (NaCl 0.9%)
  • Drug: Hypertonic solution (NaCl 3%)

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 365 Days

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • IRCCS Burlo Garofolo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ronfani Luca, MD, PhD – IRCCS Burlo Garofolo
  • Overall Official(s)
    • Dino Barbi, MD, Study Chair, IRCCS Burlo Garofolo, Trieste, Italy
    • Silvana Schreiber, RN, Study Director, IRCCS Burlo Garofolo, Trieste, Italy

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