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- Determine the efficacy of nebulized salbutamol/hypertonic saline combination in moderate to severe bronchiolitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebulized 0.9% Sodium Chloride | Active Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.9% Sodium Chloride | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Score Respiratory Distress | 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. | 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 |
| Hours of Hospital Stay | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Readmission | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gloria P Sosa-Bustamante, MD | Unidad Medica de Alta Especialidad Bajio 48. Hospital de Gineco - Pediatria. Instituto Mexicano del Seguro Social | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidad Medica de Alta Especialidad BajÃo No. 48 Hospital de Gineco - PediatrÃa. Instituto Mexicano del Seguro Social | León | Guanajuato | 37320 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21073773 | Background | Kuzik BA, Flavin MP, Kent S, Zielinski D, Kwan CW, Adeleye A, Vegsund BC, Rossi C. Effect of inhaled hypertonic saline on hospital admission rate in children with viral bronchiolitis: a randomized trial. CJEM. 2010 Nov;12(6):477-84. doi: 10.1017/s1481803500012690. | |
| 23502662 | Background | Sharma BS, Gupta MK, Rafik SP. Hypertonic (3%) saline vs 0.93% saline nebulization for acute viral bronchiolitis: a randomized controlled trial. Indian Pediatr. 2013 Aug;50(8):743-7. doi: 10.1007/s13312-013-0216-8. Epub 2012 Dec 5. |
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We have your membership number social security and personal data such as address and telephone number of the parents.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
In the follow-up period it was possible to obtain more patients from the baseline estimate of the sample number.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Score Respiratory Distress | 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. | All patients with respiratory distress in moderate to severe stage until a stage of mild respiratory distress or difficulty breathing submitted. | Posted | Median | 95% Confidence Interval | units on a scale | 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 |
|
1 month
Since their admission to the trial, until a month after discharge.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gloria Patricia Sosa-Bustamante | Instituto Mexicano del Seguro Social | 01 52 4777174800 | 31828 | patriciasosab@hotmail.com |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D012135 | Respiratory Sounds |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| 3% Sodium Chloride | Drug | 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. |
|
|
| 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. |
| Frequency of Complications of the Disease Itself | The presence or absence of clinical data to warrant dehydration of hydration, infected by bacteria, pneumothorax, interstitial emphysema and subcutaneous be evaluated. | 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. |
| 22080619 | Background | Gupta N, Puliyel A, Manchanda A, Puliyel J. Nebulized hypertonic-saline vs epinephrine for bronchiolitis; proof of concept study of cumulative sum (CUSUM) analysis. Indian Pediatr. 2012 Jul;49(7):543-7. doi: 10.1007/s13312-012-0122-5. Epub 2010 Oct 30. |
| 20646715 | Background | Al-Ansari K, Sakran M, Davidson BL, El Sayyed R, Mahjoub H, Ibrahim K. Nebulized 5% or 3% hypertonic or 0.9% saline for treating acute bronchiolitis in infants. J Pediatr. 2010 Oct;157(4):630-4, 634.e1. doi: 10.1016/j.jpeds.2010.04.074. Epub 2010 Jun 19. |
| 20636429 | Background | Luo Z, Fu Z, Liu E, Xu X, Fu X, Peng D, Liu Y, Li S, Zeng F, Yang X. Nebulized hypertonic saline treatment in hospitalized children with moderate to severe viral bronchiolitis. Clin Microbiol Infect. 2011 Dec;17(12):1829-33. doi: 10.1111/j.1469-0691.2010.03304.x. Epub 2010 Jul 15. |
| 19884591 | Background | Grewal S, Ali S, McConnell DW, Vandermeer B, Klassen TP. A randomized trial of nebulized 3% hypertonic saline with epinephrine in the treatment of acute bronchiolitis in the emergency department. Arch Pediatr Adolesc Med. 2009 Nov;163(11):1007-12. doi: 10.1001/archpediatrics.2009.196. |
| 19674354 | Background | Luo Z, Liu E, Luo J, Li S, Zeng F, Yang X, Fu Z. Nebulized hypertonic saline/salbutamol solution treatment in hospitalized children with mild to moderate bronchiolitis. Pediatr Int. 2010 Apr;52(2):199-202. doi: 10.1111/j.1442-200X.2009.02941.x. Epub 2009 Aug 7. |
| 21352671 | Background | Postiaux G, Louis J, Labasse HC, Gerroldt J, Kotik AC, Lemuhot A, Patte C. Evaluation of an alternative chest physiotherapy method in infants with respiratory syncytial virus bronchiolitis. Respir Care. 2011 Jul;56(7):989-94. doi: 10.4187/respcare.00721. Epub 2011 Feb 22. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Saline Solution 0.9% (SS 0.9%) Group | 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. |
|
|
| Primary | Hours of Hospital Stay | 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. | All patients included in the study, underwent measurement of hours of hospital stay from admission to pediatric emergencies to hospital discharge. | Posted | Median | 95% Confidence Interval | hours | 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. |
|
|
|
| Secondary | Hospital Readmission | 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. | Not Posted | May 2017 | 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. | Participants |
| Secondary | Frequency of Complications of the Disease Itself | The presence or absence of clinical data to warrant dehydration of hydration, infected by bacteria, pneumothorax, interstitial emphysema and subcutaneous be evaluated. | Not Posted | May 2017 | 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. | Participants |
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | 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. | 0 | 31 | 0 | 31 | 0 | 31 |
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| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |