Efficacy of hypertonic saline in acute bronchiolitis

A randomized clinical trial to compare efficacy of nebulized hypertonic saline and normal saline in Length of hospital stay and severity score in children with acute bronchiolitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20141201020175N3

Enrollment

120

Registered

2018-03-02

Start date

2014-09-23

Completion date

Unknown

Last updated

2018-03-26

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

Conditions

Acute bronchiolitis. with bronchospasm

Interventions

Intervention 1: Nebulize of 4 mL normal saline(0.9%) with 1.5 mL of epinephrine (1 /1000) through the mouth mask with 4 L / min oxygen

every 4 hours. Intervention 2: Intervention group: Nebulize of 4 mL hypertonic saline(3%) with 1.5 mL of epinephrine through the mouth mask with oxygen

every 4 hours. Intervention 3: Intervention group: Nebulize of 4 mL hypertonic saline(5%) with 1.5 mL of epinephrine through the mouth mask with oxygen

every 4 hours. Intervention 4: Intervention group: Nebulize of 4 mL hypertonic saline(7%) with 1.5 mL of epinephrine through the mouth mask with oxygen

every 4 hours.

Eligibility

Sex/Gender

All

Age

1 Months to 2 Years

Inclusion criteria

Inclusion criteria: acute onset of respiratory distress prodromal respiratory symptoms presence of wheezing on examination severity score (BRAS) equal five or more infants 1-24 months old

Exclusion criteria

Exclusion criteria: history of atopy history of prematurity (birth before 34 weeks or equal to) history of wheezing history of previous use of bronchodilators or glucocorticoids use loss of consciousness history of chronic heart, pulmonary, neurologic, oncologic and immunologic disease

Design outcomes

Primary

Measure	Time frame
Bronchiolitis respiratory assessment score (BRAS). Timepoint: Before intervention and then every 4 hours. Method of measurement: Bronchiolitis respiratory assessment score (BRAS).;Length of hospital stay. Timepoint: At discharge. Method of measurement: Patient record.	—

Secondary

Measure	Time frame
Respiratory rate. Timepoint: Before intervention and then every 4 hour. Method of measurement: observation.;Temperature. Timepoint: Before intervention and then every 4 hour. Method of measurement: Thermometer.;Heart rate. Timepoint: Before intervention and then every 4 hour. Method of measurement: determining pulse rate by use a chronometer.;O2 saturation. Timepoint: Before intervention and then every 4 hour. Method of measurement: pulse oximeter.	—

Measure

Time frame

Respiratory rate. Timepoint: Before intervention and then every 4 hour. Method of measurement: observation.;Temperature. Timepoint: Before intervention and then every 4 hour. Method of measurement: Thermometer.;Heart rate. Timepoint: Before intervention and then every 4 hour. Method of measurement: determining pulse rate by use a chronometer.;O2 saturation. Timepoint: Before intervention and then every 4 hour. Method of measurement: pulse oximeter.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohsen Reisi

Vice-chancellor of research of Isfahan University of Medical Sciences

Mohsenreisi72@yahoo.com+98 31 3629 5672

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026