Trial Outcomes & Findings for Hypertonic Saline for Acute Bronchiolitis (NCT NCT01247064)
NCT ID: NCT01247064
Last Updated: 2014-08-19
Results Overview
The Respiratory Assessment Change Score (RACS) assesses change in respiratory status using the change in the Respiratory Distress Assessment Instrument (RDAI) and a standardized change in respiratory rate, with points being assigned by change increments of 10%. Thus, a change in respiratory rate of ≤5% from baseline counted as a change of 0 units, decrease/increase of 6% to 15% counted as improvement/deterioration of 1 unit, etc. The overall RACS is the arithmetic sum of the RDAI change and the standardized respiratory rate change between assessments with a decrease in RACS signifying improvement.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
62 participants
Primary outcome timeframe
Baseline and 1 hour
Results posted on
2014-08-19
Participant Flow
Participant milestones
| Measure |
Nebulized 3% Saline
Nebulized 3% saline: 4 mL of nebulized 3% saline once
|
Nebulized 0.9% Normal Saline
Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
COMPLETED
|
31
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hypertonic Saline for Acute Bronchiolitis
Baseline characteristics by cohort
| Measure |
Nebulized 3% Saline
n=31 Participants
Nebulized 3% saline: 4 mL of nebulized 3% saline once
|
Nebulized 0.9% Normal Saline
n=31 Participants
Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.2 months
STANDARD_DEVIATION 5.1 • n=5 Participants
|
6.1 months
STANDARD_DEVIATION 3.6 • n=7 Participants
|
6.6 months
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
24 participants
n=5 Participants
|
23 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Eczema History
Yes
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Eczema History
No
|
21 participants
n=5 Participants
|
23 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Eczema History
Unknown
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Family History of Atopy
No
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Family History of Atopy
Yes
|
22 participants
n=5 Participants
|
24 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Family History of Atopy
Unknown
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Days of Symptoms
|
3.4 days
STANDARD_DEVIATION 3.7 • n=5 Participants
|
3.4 days
STANDARD_DEVIATION 2.4 • n=7 Participants
|
3.4 days
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Smokers in Household
No
|
14 participants
n=5 Participants
|
17 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Smokers in Household
Yes
|
17 participants
n=5 Participants
|
13 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Smokers in Household
Unknown
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
ICU History
No
|
23 participants
n=5 Participants
|
27 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
ICU History
Yes
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
ICU History
Unknown
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Respiratory Distress Assessment Instrument Score
|
7.8 units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
7.4 units on a scale
STANDARD_DEVIATION 2.5 • n=7 Participants
|
7.6 units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Respiratory Rate
|
49.6 breaths per minute
STANDARD_DEVIATION 12.4 • n=5 Participants
|
52.4 breaths per minute
STANDARD_DEVIATION 12.4 • n=7 Participants
|
50.9 breaths per minute
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Heart Rate
|
153.4 beats per minute
STANDARD_DEVIATION 18.4 • n=5 Participants
|
159.3 beats per minute
STANDARD_DEVIATION 21.9 • n=7 Participants
|
156.5 beats per minute
STANDARD_DEVIATION 20 • n=5 Participants
|
|
Oxygen Saturation
|
95.4 percent
STANDARD_DEVIATION 3.8 • n=5 Participants
|
96.3 percent
STANDARD_DEVIATION 3.7 • n=7 Participants
|
95.9 percent
STANDARD_DEVIATION 3.7 • n=5 Participants
|
|
Physician Clinical Impression
Mild
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Physician Clinical Impression
Moderate
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Physician Clinical Impression
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 hourThe Respiratory Assessment Change Score (RACS) assesses change in respiratory status using the change in the Respiratory Distress Assessment Instrument (RDAI) and a standardized change in respiratory rate, with points being assigned by change increments of 10%. Thus, a change in respiratory rate of ≤5% from baseline counted as a change of 0 units, decrease/increase of 6% to 15% counted as improvement/deterioration of 1 unit, etc. The overall RACS is the arithmetic sum of the RDAI change and the standardized respiratory rate change between assessments with a decrease in RACS signifying improvement.
Outcome measures
| Measure |
Nebulized 3% Saline
n=31 Participants
Nebulized 3% saline: 4 mL of nebulized 3% saline once
|
Nebulized 0.9% Normal Saline
n=31 Participants
Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
|
|---|---|---|
|
Respiratory Assessment Change Score (RACS)
|
-1.5 units on a scale
Interval -3.1 to 0.2
|
-4 units on a scale
Interval -5.3 to -2.7
|
SECONDARY outcome
Timeframe: 1 dayOutcome measures
| Measure |
Nebulized 3% Saline
n=31 Participants
Nebulized 3% saline: 4 mL of nebulized 3% saline once
|
Nebulized 0.9% Normal Saline
n=31 Participants
Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
|
|---|---|---|
|
Rate of Hospitalization
|
71 percentage of participants
|
64.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 1 hourOutcome measures
| Measure |
Nebulized 3% Saline
n=31 Participants
Nebulized 3% saline: 4 mL of nebulized 3% saline once
|
Nebulized 0.9% Normal Saline
n=31 Participants
Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
|
|---|---|---|
|
Respiratory Rate Change
|
-1.8 breaths per minute
Interval -6.5 to 2.8
|
-9.8 breaths per minute
Interval -14.6 to -4.9
|
SECONDARY outcome
Timeframe: Baseline and 1 hourOutcome measures
| Measure |
Nebulized 3% Saline
n=31 Participants
Nebulized 3% saline: 4 mL of nebulized 3% saline once
|
Nebulized 0.9% Normal Saline
n=31 Participants
Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
|
|---|---|---|
|
Oxygen Saturation Change
|
1.1 percent
Interval -0.4 to 2.6
|
0.1 percent
Interval -1.6 to 1.8
|
SECONDARY outcome
Timeframe: 1 hourOutcome measures
| Measure |
Nebulized 3% Saline
n=31 Participants
Nebulized 3% saline: 4 mL of nebulized 3% saline once
|
Nebulized 0.9% Normal Saline
n=31 Participants
Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
|
|---|---|---|
|
Parental Perception of Improvement of Breathing After Study Medication
|
50 percentage of participants
|
54.8 percentage of participants
|
Adverse Events
Nebulized 3% Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nebulized 0.9% Normal Saline
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
Todd Florin
Cincinnati Children's Hospital Medical Center
Phone: 513-636-7966
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place