Trial Outcomes & Findings for Nebulized 3% Hypertonic Saline Solution Treatment of Bronchiolitis in Infants (NCT NCT02233985)
NCT ID: NCT02233985
Last Updated: 2017-06-21
Results Overview
It is a validated clinical scale, sufficiently reliable measure of Severity of the respiratory distress. It consists of the summation score of the sibilance / crackling parameters (the largest of them), respiratory effort, pulmonary air inlet, oxygen saturation, heart rate and breathing rate. It is stratified into 3 levels of severity: mild from 0 to 5 points, moderate from 6 to 10 and severe from 10 to 16.
COMPLETED
PHASE4
64 participants
Basal, 30 minutes after the end of the first 3 continuous nebulization sessions, at 4 hours, 8 hours and every 24 hours during the entire hospital stay
2017-06-21
Participant Flow
Participant milestones
| Measure |
Nebulized 0.9% Sodium Chloride
Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
0.9% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
|
Nebulized 3% Sodium Chloride
Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
3% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
31
|
|
Overall Study
COMPLETED
|
33
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nebulized 3% Hypertonic Saline Solution Treatment of Bronchiolitis in Infants
Baseline characteristics by cohort
| Measure |
Nebulized 0.9% Sodium Chloride
n=33 Participants
Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
0.9% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
|
Nebulized 3% Sodium Chloride
n=31 Participants
Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
3% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.7 months
STANDARD_DEVIATION 5.7 • n=5 Participants
|
8.8 months
STANDARD_DEVIATION 5.7 • n=7 Participants
|
8.2 months
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Basal, 30 minutes after the end of the first 3 continuous nebulization sessions, at 4 hours, 8 hours and every 24 hours during the entire hospital stayPopulation: All patients with respiratory distress in moderate to severe stage until a stage of mild respiratory distress or difficulty breathing submitted.
It is a validated clinical scale, sufficiently reliable measure of Severity of the respiratory distress. It consists of the summation score of the sibilance / crackling parameters (the largest of them), respiratory effort, pulmonary air inlet, oxygen saturation, heart rate and breathing rate. It is stratified into 3 levels of severity: mild from 0 to 5 points, moderate from 6 to 10 and severe from 10 to 16.
Outcome measures
| Measure |
Hypertonic Saline Solution 3% (HSS 3%) Group
n=31 Participants
Patients with moderate stages (6 to 10 points) and severe (11 to 16 points) were selected, performing subsequent measurements always 30 minutes after nebulization corresponding.
|
Saline Solution 0.9% (SS 0.9%) Group
n=33 Participants
Patients with moderate stages (6 to 10 points) and severe (11 to 16 points) were selected, performing subsequent measurements always 30 minutes after nebulization corresponding.
|
|---|---|---|
|
Score Respiratory Distress
144 hours
|
0 units on a scale
Interval 0.0 to 0.0
|
6 units on a scale
Interval 6.0 to 6.0
|
|
Score Respiratory Distress
Basal
|
8 units on a scale
Interval 7.0 to 10.0
|
8 units on a scale
Interval 8.0 to 10.0
|
|
Score Respiratory Distress
30 minutes
|
6 units on a scale
Interval 5.0 to 7.0
|
8 units on a scale
Interval 8.0 to 9.0
|
|
Score Respiratory Distress
4 hours
|
5 units on a scale
Interval 3.0 to 6.0
|
8 units on a scale
Interval 7.0 to 9.0
|
|
Score Respiratory Distress
8 hours
|
3 units on a scale
Interval 3.0 to 5.0
|
8 units on a scale
Interval 6.0 to 9.0
|
|
Score Respiratory Distress
12 hours
|
3 units on a scale
Interval 2.0 to 7.0
|
7 units on a scale
Interval 6.0 to 9.0
|
|
Score Respiratory Distress
24 hours
|
0 units on a scale
Interval 0.0 to 0.0
|
7 units on a scale
Interval 6.0 to 9.0
|
|
Score Respiratory Distress
48 hours
|
0 units on a scale
Interval 0.0 to 0.0
|
7 units on a scale
Interval 6.0 to 9.0
|
|
Score Respiratory Distress
72 hours
|
0 units on a scale
Interval 0.0 to 0.0
|
6 units on a scale
Interval 3.0 to 7.0
|
|
Score Respiratory Distress
96 hours
|
0 units on a scale
Interval 0.0 to 0.0
|
5 units on a scale
Interval 4.0 to 9.0
|
|
Score Respiratory Distress
120 hours
|
0 units on a scale
Interval 0.0 to 0.0
|
3 units on a scale
Interval 3.0 to 3.0
|
|
Score Respiratory Distress
196 hours
|
0 units on a scale
Interval 0.0 to 0.0
|
4 units on a scale
Interval 4.0 to 4.0
|
PRIMARY outcome
Timeframe: Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.Population: All patients included in the study, underwent measurement of hours of hospital stay from admission to pediatric emergencies to hospital discharge.
Each patient record the time of entry and measured the total hospital stay time in hours, recording the time of discharge to determine the total stay in hours. The hospital stay will be evaluated in hours. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.
Outcome measures
| Measure |
Hypertonic Saline Solution 3% (HSS 3%) Group
n=31 Participants
Patients with moderate stages (6 to 10 points) and severe (11 to 16 points) were selected, performing subsequent measurements always 30 minutes after nebulization corresponding.
|
Saline Solution 0.9% (SS 0.9%) Group
n=33 Participants
Patients with moderate stages (6 to 10 points) and severe (11 to 16 points) were selected, performing subsequent measurements always 30 minutes after nebulization corresponding.
|
|---|---|---|
|
Hours of Hospital Stay
|
8 hours
Interval 5.4 to 9.0
|
39.3 hours
Interval 23.9 to 61.6
|
SECONDARY outcome
Timeframe: Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.After the first admission of each patient will be evaluated during the next 30 days, if a patient is readmitted for any respiratory disease, respiratory distress, pneumonia or bronchiolitis. Considering as non-serious risks that do not compromise life, tachycardia, tremor, increased access to cough immediately to the inhalation, as well as the ardor of nasal mucosa, all these with limited characteristics, however, these do not put at risk The health of the patient, so they were not measured.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.The presence or absence of clinical data to warrant dehydration of hydration, infected by bacteria, pneumothorax, interstitial emphysema and subcutaneous be evaluated.
Outcome measures
Outcome data not reported
Adverse Events
Nebulized 0.9% Sodium Chloride
Nebulized 3% Sodium Chloride
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Gloria Patricia Sosa-Bustamante
Instituto Mexicano del Seguro Social
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place