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Trial record 63 of 107 for:    ( Map: Nepal )

Efficacy of Nebulised Hypertonic Saline (3%) Among Children With Bronchiolitis.

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ClinicalTrials.gov Identifier: NCT01276821
Recruitment Status : Completed
First Posted : January 13, 2011
Results First Posted : May 31, 2013
Last Update Posted : May 31, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Aayush Khanal, MD, Tribhuvan University Teaching Hospital, Institute Of Medicine.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Bronchiolitis
Interventions Drug: L-Epinephrine and Normal Saline (0.9%)
Drug: L-Epinephrine and Hypertonic Saline (3%)
Enrollment 100

Recruitment Details

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.

Pre-assignment Details  
Arm/Group Title Standard Study
Hide Arm/Group Description Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
Period Title: Overall Study
Started 50 50
Completed 50 49
Not Completed 0 1
Reason Not Completed
Protocol Violation             0             1
Arm/Group Title Standard Study Total
Hide Arm/Group Description Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
<=18 years
50
 100.0%
50
 100.0%
100
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 50 participants 50 participants 100 participants
9.82  (5.06) 9.51  (4.28) 9.66  (4.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
29
  58.0%
23
  46.0%
52
  52.0%
Male
21
  42.0%
27
  54.0%
48
  48.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Nepal Number Analyzed 50 participants 50 participants 100 participants
50 50 100
Duration of illness (days)  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 50 participants 50 participants 100 participants
3.33  (0.96) 3.43  (1.02) 3.38  (0.99)
Clinical Severity Score Units   [1] 
Mean (Standard Deviation)
Unit of measure:  Clinical Severity Score Units
Number Analyzed 50 participants 50 participants 100 participants
5.2  (1.1) 5.3  (1.6) 5.25  (1.35)
[1]
Measure Description:

The Clinical Severity scoring system initially described by Wang, assesses respiratory rate, wheezing, retraction, and general condition,to assess the degree of respiratory distress in young children. It provides a score ranging from 0 to 12, with increased severity receiving a higher score.

These 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.

Respiratory Rate  
Mean (Standard Deviation)
Unit of measure:  Breaths per minute
Number Analyzed 50 participants 50 participants 100 participants
49  (2) 49.1  (2.5) 49.05  (2.25)
Spo2 (Oxygen Saturation)  
Mean (Standard Deviation)
Unit of measure:  Percentage of Oxygen Saturation
Number Analyzed 50 participants 50 participants 100 participants
93.5  (0.7) 93.4  (0.8) 93.45  (0.75)
Heart rate  
Mean (Standard Deviation)
Unit of measure:  Beats per minute
Number Analyzed 50 participants 50 participants 100 participants
149.7  (7.1) 148.7  (7.5) 149.2  (7.3)
Temperature  
Mean (Standard Deviation)
Unit of measure:  Degrees Fahreinheit
Number Analyzed 50 participants 50 participants 100 participants
99.2  (0.6) 99.1  (0.6) 99.15  (0.6)
Family History of Asthma,  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Positive 5 4 9
Negative 45 46 91
Parental Smoking   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Yes 21 30 51
No 29 20 49
[1]
Measure Description: History of parental Smoking (Secondhand passive smoke exposure status) of children
Enrollment from Emergency Department  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Enrollment from Emergency Room 2 2 4
Enrollment from Out-Patient Department 48 48 96
Exposure to Biofuels  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Yes 8 14 22
No 42 36 78
Breastfeeding Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Yes 48 48 96
No 2 2 4
Prematurity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Yes 2 3 5
No 48 47 95
History suggestive of Atopy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Yes 3 7 10
No 47 43 90
1.Primary Outcome
Title Mean Change in Clinical Severity Score
Hide Description

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.

Time Frame 2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Study
Hide Arm/Group Description:
Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.26  (1.15) 3.57  (1.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard, Study
Comments

Null Hypothesis Efficacy of nebulised hypertonic saline (3%) with L-Epinephrine is not higer than as compared to L-Epinephrine given with 0.9% normal saline in the management of children aged 6 weeks to 24 months with mild to moderately severe bronchiolitis.

Alternate Hypothesis:

Nebulised hypertonic saline (3%) with L-Epinephrine is superior to 0.9% Normal saline with L-Epinephrine in the management of children aged 6 weeks to 24 months with mild to moderately severe bronchiolitis.

Type of Statistical Test Non-Inferiority or Equivalence
Comments Non - Inferiority Analysis
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
0.78 to 1.82
Parameter Dispersion
Type: Standard Deviation
Value: 1.30
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Patients Meeting Eligibility Criteria for ER/ OPD Discharge at the End of 2 Hours of Observation
Hide Description [Not Specified]
Time Frame At the end of 2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Study
Hide Arm/Group Description:
Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: participants
Meets Criteria for ER/OPD discharge after 120 mins 15 35
Does not meet criteria for ER/OPD discharge 35 15
3.Secondary Outcome
Title Relapse Rate
Hide Description To study the number of patients in either group who need another unscheduled medical visit within the initial 24 hours of ER/ OPD visit
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Study
Hide Arm/Group Description:
Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: Participants
Hospital Re-visit within 24 hours 15 5
No Hospital Re-visit within 24 hours 35 45
4.Secondary Outcome
Title Need for Unscheduled Medical Visits, if Any, for Same Symptoms to Any Healthcare Facility Within 1 Week
Hide Description [Not Specified]
Time Frame 7 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Study
Hide Arm/Group Description:
Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: participants
Unscheduled medical Visits in 1 week 23 18
No Unscheduled medical visits in 1 week 27 32
5.Secondary Outcome
Title Missed Days of Work of Caregivers
Hide Description Number 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.
Time Frame 7 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Study
Hide Arm/Group Description:
Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: participants
10 3
6.Secondary Outcome
Title Persistence of Cough at the End of 1 Week
Hide Description Number of patients in each intervention group whose parents reported the persistence of initial cough at the end of 1 week in their children.
Time Frame 7 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Study
Hide Arm/Group Description:
Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: participants
Persistence of cough at the end of 1 week 37 31
Absence of cough at the end of 1 week 13 19
7.Other Pre-specified Outcome
Title Average Duration of Crying (in Minutes) Among Babies Receiving Nebulisation Therapy.
Hide Description The 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.
Time Frame 2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Study
Hide Arm/Group Description:
Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: Minutes
2.16  (0.79) 2.03  (0.90)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Study
Hide Arm/Group Description Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
All-Cause Mortality
Standard Study
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Study
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Standard Study
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Aayush Khanal
Organization: Department of Child Health, Tribhuvan University Teaching Hospital, Institute of Medicine.
Phone: 977-1-4421532
Responsible Party: Dr. Aayush Khanal, MD, Tribhuvan University Teaching Hospital, Institute Of Medicine.
ClinicalTrials.gov Identifier: NCT01276821     History of Changes
Other Study ID Numbers: PEDSTUTHIOM
First Submitted: January 12, 2011
First Posted: January 13, 2011
Results First Submitted: September 11, 2012
Results First Posted: May 31, 2013
Last Update Posted: May 31, 2013