Trial Outcomes & Findings for Efficacy of Nebulized Hypertonic Saline in the Treatment of Acute Bronchiolitis (NCT NCT01238848)
NCT ID: NCT01238848
Last Updated: 2017-02-10
Results Overview
hospitalization days
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
Participants will be followed for the duration of hospitalization, an expected average of 4 days
Results posted on
2017-02-10
Participant Flow
Participant milestones
| Measure |
Hypertonic
Hypertonic saline (sodium chloride 0.3%) + albuterol
|
Normal
Normal saline (sodium chloride 0.9%) + albuterol
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
37
|
45
|
|
Overall Study
NOT COMPLETED
|
13
|
5
|
Reasons for withdrawal
| Measure |
Hypertonic
Hypertonic saline (sodium chloride 0.3%) + albuterol
|
Normal
Normal saline (sodium chloride 0.9%) + albuterol
|
|---|---|---|
|
Overall Study
Physician Decision
|
13
|
5
|
Baseline Characteristics
Efficacy of Nebulized Hypertonic Saline in the Treatment of Acute Bronchiolitis
Baseline characteristics by cohort
| Measure |
Hypertonic
n=50 Participants
Hypertonic saline (sodium chloride 0.3%) + albuterol
|
Normal
n=50 Participants
Normal saline (sodium chloride 0.9%) + albuterol
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
4.6 months
STANDARD_DEVIATION 4.1 • n=5 Participants
|
4.2 months
STANDARD_DEVIATION 2.5 • n=7 Participants
|
4.5 months
STANDARD_DEVIATION 3.8 • n=5 Participants
|
|
Gender
Female
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Gender
Male
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of hospitalization, an expected average of 4 dayshospitalization days
Outcome measures
| Measure |
Hypertonic
n=37 Participants
Hypertonic saline (sodium chloride 0.3%) + albuterol
|
Normal
n=45 Participants
Normal saline (sodium chloride 0.9%) + albuterol
|
|---|---|---|
|
Hospitalization Days
|
5.8 days
Standard Deviation 2.7
|
5.47 days
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospitalization, an expected average of 4 daysLength of oxygen use (days)
Outcome measures
| Measure |
Hypertonic
n=37 Participants
Hypertonic saline (sodium chloride 0.3%) + albuterol
|
Normal
n=45 Participants
Normal saline (sodium chloride 0.9%) + albuterol
|
|---|---|---|
|
Length of Oxygen Use
|
4 days
Standard Deviation 3.4
|
3.22 days
Standard Deviation 2.3
|
Adverse Events
Hypertonic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Maria I. Espelt, MD
Hospital General de Niños Pedro de Elizalde
Phone: 541146136968
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place