Bronchiolitis
Conditions
Keywords
Hypertonic, Saline, Bronchiolitis, Efficacy
Brief summary
The purpose of this study is to evaluate the efficacy of hypertonic saline vs. normal saline in the treatment of infants hospitalized for bronchiolitis, regarding length of hospital stay, oxygen requirements and clinical outcome.
Detailed description
Despite bronchiolitis is a very frequent disease among infants, there are still controversies regarding its treatment. Hypertonic saline has been proposed as useful treatment in these children, bur information is still controversial. The aim is to asses that using Nebulized Hypertonic Saline with bronchodilators (albuterol) may reduce the days of hospitalization and improve clinical outcomes in patients with acute bronchiolitis, compared with using Normal Saline with albuterol.
Interventions
DRUGHypertonic saline
3 cc nebulized hypertonic saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days
DRUGNormal saline
3 cc nebulized normal saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days
Sponsors
Hospital General de Niños Pedro de Elizalde
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 2 Years
Healthy volunteers
No
Inclusion criteria
* Infants aged 1 to 24 months, hospitalized for first episode of bronchiolitis, with severity score ≥ 5 points and oxygen saturation ≥ 97%.
Exclusion criteria
* Chronic respiratory or cardiovascular disease, respiratory failure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization Days | Participants will be followed for the duration of hospitalization, an expected average of 4 days | hospitalization days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Oxygen Use | Participants will be followed for the duration of hospitalization, an expected average of 4 days | Length of oxygen use (days) |
Countries
Argentina
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hypertonic Hypertonic saline (sodium chloride 0.3%) + albuterol | 50 |
| Normal Normal saline (sodium chloride 0.9%) + albuterol | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 13 | 5 |
Baseline characteristics
| Characteristic | Hypertonic | Normal | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 50 Participants | 50 Participants | 100 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 4.6 months STANDARD_DEVIATION 4.1 | 4.2 months STANDARD_DEVIATION 2.5 | 4.5 months STANDARD_DEVIATION 3.8 |
| Gender Female | 24 Participants | 26 Participants | 50 Participants |
| Gender Male | 26 Participants | 24 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Hospitalization Days
hospitalization days
Time frame: Participants will be followed for the duration of hospitalization, an expected average of 4 days
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Hypertonic | Hospitalization Days | 5.8 days | Standard Deviation 2.7 |
| Normal | Hospitalization Days | 5.47 days | Standard Deviation 2.1 |
Secondary
Length of Oxygen Use
Length of oxygen use (days)
Time frame: Participants will be followed for the duration of hospitalization, an expected average of 4 days
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Hypertonic | Length of Oxygen Use | 4 days | Standard Deviation 3.4 |
| Normal | Length of Oxygen Use | 3.22 days | Standard Deviation 2.3 |