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Completed

NCT Number: NCT02162745

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.

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Key information

Conditions

Bronchiolitis Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

1 day–365 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pediatria, Azienda Ospedaliera Santa Maria Degli Angeli, Pordenone, Friuli Venezia Giulia, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isotonic solution (NaCl 0.9%)

Drug

Hypertonic solution (NaCl 3%)

Drug

Primary outcomes

  1. Oxygen saturation (%)

    Time frame: up to 50 minutes after allocation

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

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 13, 2014
Registry last updated
Jun 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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