Nasal Irrigation in Infants With Bronchiolitis.

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02162745

Enrollment

133

Registered

2014-06-13

Start date

2012-10-31

Completion date

2014-05-31

Last updated

2014-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis

Keywords

Bronchiolitis, Normal saline solution, Hypertonic solution, Nasal irrigation

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.

Interventions

DRUGIsotonic solution (NaCl 0.9%)

DRUGHypertonic solution (NaCl 3%)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 365 Days

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Respiratory effort (WARME score)	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).

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026