Trial Outcomes & Findings for Efficacy of Nebulised Hypertonic Saline (3%) Among Children With Bronchiolitis. (NCT NCT01276821)
NCT ID: NCT01276821
Last Updated: 2013-05-31
Results Overview
Mean changes in the Clinical Severity Score after 2 sessions of nebulisation as compared to baseline. Clinical Severity Score devised by Wang et al, is an objective scoring system that measures the degree of respiratory distress in young children. The scoring system assesses respiratory rate, wheezing, retraction, and general condition,scores ranging from 0 to 3, with higher scores indicating severe illness and vice versa. The total scores range from 0 to 12, with increased severity receiving a higher score (Wang et al, 1992). This scoring systems have previously been validated in a number of well designed randomized controlled trials(Anil 2010, Kuzik 2007, Sarrell 2002, and Mandelberg 2003). A 1 point improvement in the clinical severity score implies approximately 7% betterment of symptoms on the scale.
COMPLETED
PHASE4
100 participants
2 hours
2013-05-31
Participant Flow
Subjects were recruited from previously healthy children aged 6 weeks to 24 months with first episode of wheezing who visited the OPD and ER of Kanti Children Hospital and met the clinical definition of bronchiolitis. Recruitment occurred on weekdays from 8:00 to 17:00 Hours. Out of 754 screened children, 159 were first episode wheezers.
Participant milestones
| Measure |
Standard
Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
|
Study
Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Standard
Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
|
Study
Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Efficacy of Nebulised Hypertonic Saline (3%) Among Children With Bronchiolitis.
Baseline characteristics by cohort
| Measure |
Standard
n=50 Participants
Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
|
Study
n=50 Participants
Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
50 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
100 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age Continuous
|
9.82 months
STANDARD_DEVIATION 5.06 • n=93 Participants
|
9.51 months
STANDARD_DEVIATION 4.28 • n=4 Participants
|
9.66 months
STANDARD_DEVIATION 4.67 • n=27 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Region of Enrollment
Nepal
|
50 participants
n=93 Participants
|
50 participants
n=4 Participants
|
100 participants
n=27 Participants
|
|
Duration of illness (days)
|
3.33 Days
STANDARD_DEVIATION 0.96 • n=93 Participants
|
3.43 Days
STANDARD_DEVIATION 1.02 • n=4 Participants
|
3.38 Days
STANDARD_DEVIATION 0.99 • n=27 Participants
|
|
Clinical Severity Score Units
|
5.2 Clinical Severity Score Units
STANDARD_DEVIATION 1.1 • n=93 Participants
|
5.3 Clinical Severity Score Units
STANDARD_DEVIATION 1.6 • n=4 Participants
|
5.25 Clinical Severity Score Units
STANDARD_DEVIATION 1.35 • n=27 Participants
|
|
Respiratory Rate
|
49 Breaths per minute
STANDARD_DEVIATION 2 • n=93 Participants
|
49.1 Breaths per minute
STANDARD_DEVIATION 2.5 • n=4 Participants
|
49.05 Breaths per minute
STANDARD_DEVIATION 2.25 • n=27 Participants
|
|
Spo2 (Oxygen Saturation)
|
93.5 Percentage of Oxygen Saturation
STANDARD_DEVIATION 0.7 • n=93 Participants
|
93.4 Percentage of Oxygen Saturation
STANDARD_DEVIATION 0.8 • n=4 Participants
|
93.45 Percentage of Oxygen Saturation
STANDARD_DEVIATION 0.75 • n=27 Participants
|
|
Heart rate
|
149.7 Beats per minute
STANDARD_DEVIATION 7.1 • n=93 Participants
|
148.7 Beats per minute
STANDARD_DEVIATION 7.5 • n=4 Participants
|
149.2 Beats per minute
STANDARD_DEVIATION 7.3 • n=27 Participants
|
|
Temperature
|
99.2 Degrees Fahreinheit
STANDARD_DEVIATION 0.6 • n=93 Participants
|
99.1 Degrees Fahreinheit
STANDARD_DEVIATION 0.6 • n=4 Participants
|
99.15 Degrees Fahreinheit
STANDARD_DEVIATION 0.6 • n=27 Participants
|
|
Family History of Asthma,
Positive
|
5 participants
n=93 Participants
|
4 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Family History of Asthma,
Negative
|
45 participants
n=93 Participants
|
46 participants
n=4 Participants
|
91 participants
n=27 Participants
|
|
Parental Smoking
Yes
|
21 participants
n=93 Participants
|
30 participants
n=4 Participants
|
51 participants
n=27 Participants
|
|
Parental Smoking
No
|
29 participants
n=93 Participants
|
20 participants
n=4 Participants
|
49 participants
n=27 Participants
|
|
Enrollment from Emergency Department
Enrollment from Emergency Room
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Enrollment from Emergency Department
Enrollment from Out-Patient Department
|
48 participants
n=93 Participants
|
48 participants
n=4 Participants
|
96 participants
n=27 Participants
|
|
Exposure to Biofuels
Yes
|
8 participants
n=93 Participants
|
14 participants
n=4 Participants
|
22 participants
n=27 Participants
|
|
Exposure to Biofuels
No
|
42 participants
n=93 Participants
|
36 participants
n=4 Participants
|
78 participants
n=27 Participants
|
|
Breastfeeding Status
Yes
|
48 participants
n=93 Participants
|
48 participants
n=4 Participants
|
96 participants
n=27 Participants
|
|
Breastfeeding Status
No
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Prematurity
Yes
|
2 participants
n=93 Participants
|
3 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Prematurity
No
|
48 participants
n=93 Participants
|
47 participants
n=4 Participants
|
95 participants
n=27 Participants
|
|
History suggestive of Atopy
Yes
|
3 participants
n=93 Participants
|
7 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
History suggestive of Atopy
No
|
47 participants
n=93 Participants
|
43 participants
n=4 Participants
|
90 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 hoursMean changes in the Clinical Severity Score after 2 sessions of nebulisation as compared to baseline. Clinical Severity Score devised by Wang et al, is an objective scoring system that measures the degree of respiratory distress in young children. The scoring system assesses respiratory rate, wheezing, retraction, and general condition,scores ranging from 0 to 3, with higher scores indicating severe illness and vice versa. The total scores range from 0 to 12, with increased severity receiving a higher score (Wang et al, 1992). This scoring systems have previously been validated in a number of well designed randomized controlled trials(Anil 2010, Kuzik 2007, Sarrell 2002, and Mandelberg 2003). A 1 point improvement in the clinical severity score implies approximately 7% betterment of symptoms on the scale.
Outcome measures
| Measure |
Standard
n=50 Participants
Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
|
Study
n=50 Participants
Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
|
|---|---|---|
|
Mean Change in Clinical Severity Score
|
2.26 units on a scale
Standard Deviation 1.15
|
3.57 units on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: At the end of 2 hoursOutcome measures
| Measure |
Standard
n=50 Participants
Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
|
Study
n=50 Participants
Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
|
|---|---|---|
|
Patients Meeting Eligibility Criteria for ER/ OPD Discharge at the End of 2 Hours of Observation
Meets Criteria for ER/OPD discharge after 120 mins
|
15 participants
|
35 participants
|
|
Patients Meeting Eligibility Criteria for ER/ OPD Discharge at the End of 2 Hours of Observation
Does not meet criteria for ER/OPD discharge
|
35 participants
|
15 participants
|
SECONDARY outcome
Timeframe: 24 hoursTo study the number of patients in either group who need another unscheduled medical visit within the initial 24 hours of ER/ OPD visit
Outcome measures
| Measure |
Standard
n=50 Participants
Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
|
Study
n=50 Participants
Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
|
|---|---|---|
|
Relapse Rate
Hospital Re-visit within 24 hours
|
15 Participants
|
5 Participants
|
|
Relapse Rate
No Hospital Re-visit within 24 hours
|
35 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: 7 daysOutcome measures
| Measure |
Standard
n=50 Participants
Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
|
Study
n=50 Participants
Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
|
|---|---|---|
|
Need for Unscheduled Medical Visits, if Any, for Same Symptoms to Any Healthcare Facility Within 1 Week
Unscheduled medical Visits in 1 week
|
23 participants
|
18 participants
|
|
Need for Unscheduled Medical Visits, if Any, for Same Symptoms to Any Healthcare Facility Within 1 Week
No Unscheduled medical visits in 1 week
|
27 participants
|
32 participants
|
SECONDARY outcome
Timeframe: 7 daysNumber of patients in each intervention group whose parents reported at least 1 day of missed work due to the illness of child within the week following the initial hospital visit on 7 day follow-up call.
Outcome measures
| Measure |
Standard
n=50 Participants
Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
|
Study
n=50 Participants
Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
|
|---|---|---|
|
Missed Days of Work of Caregivers
|
10 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 7 daysNumber of patients in each intervention group whose parents reported the persistence of initial cough at the end of 1 week in their children.
Outcome measures
| Measure |
Standard
n=50 Participants
Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
|
Study
n=50 Participants
Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
|
|---|---|---|
|
Persistence of Cough at the End of 1 Week
Persistence of cough at the end of 1 week
|
37 participants
|
31 participants
|
|
Persistence of Cough at the End of 1 Week
Absence of cough at the end of 1 week
|
13 participants
|
19 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 hoursThe outcomes tries to compare the influence of duration of crying among babies receiving nebulization which interferes with drug delivery and henceforth might create a confounding bias while interpreting results.
Outcome measures
| Measure |
Standard
n=50 Participants
Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
|
Study
n=50 Participants
Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
|
|---|---|---|
|
Average Duration of Crying (in Minutes) Among Babies Receiving Nebulisation Therapy.
|
2.16 Minutes
Standard Deviation 0.79
|
2.03 Minutes
Standard Deviation 0.90
|
Adverse Events
Standard
Study
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Aayush Khanal
Department of Child Health, Tribhuvan University Teaching Hospital, Institute of Medicine.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place