BronchiolitisPhase 2NCT02585531
Epinephrine, Dexamethasone and Hypertonic Saline in Bronchiolitis
A Phase 2 study testing Hypertonic Saline 3% and Epinephrine and Dexamethasone in people with Bronchiolitis, run by Hospital General Naval de Alta Especialidad - Escuela Medico Naval at 1 site in Mexico.
Trial summary
Bronchiolitis is one of the main reasons for consultation in primary care and emergency services, as well as the leading cause of hospitalization for lower respiratory tract infection in children under two years. Read more about this study
- Who is it for?
- Ages 2 to 24 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Hypertonic Saline 3% and Epinephrine and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2015to Apr 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients under 2 years of age diagnosed with bronchiolitis
- Be beneficiaries Marine
- Outpatient
- Severity of Bronchiolitis mild to moderate scale according to Difficulty rating scale Respiratory (RDAI) for bronchiolitis (RDAI score 2-8).
Who cannot join
- Patients with a history of atopy
- Patients with a history of asthma in infants.
- Patients with comorbidity
- RDAI> 9 at diagnosis.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital General Naval de Alta Especialidad
Mexico City, Mexico City, 04480
About this study
Official title: Epinephrine, Dexamethasone, and Hypertonic Saline in Children With Bronchiolitis in the Hospital General Naval de Alta Especialidad. A Randomized Controlled Trial
Bronchiolitis is one of the main reasons for consultation in primary care and emergency services, as well as the leading cause of hospitalization for lower respiratory tract infection in children under two years. There is still no consensus on the medical management of the disease, in clinical practice there is wide variability in the treatment with inhaled drugs and / or oral bronchodilators, steroids, antihistamines despite the viral etiology of the disease, which results in increased morbidity and a major economic benefit for all health services.
Several studies are in relation to the management of bronchiolitis, one of which was made during 2014 in the Naval Hospital of High Specialty which included 90 participants comparing 3 treatment. The treatments administered were: dexamethasone and epinephrine (Levogira) (ED), hypertonic saline 3% (SSH 3%)and saline 0.9% ( SS 0.9%), finding that the handling of ED and SSH 3% had lower rates of hospital admissions compared to the symptomatic management of SS 0.9%. Although the superiority of SSH3% and ED in relation to the use of SS 0.9% was demonstrated, it was not possible to establish difference statistically significant between them. Why it was considered necessary to continue the study focused on determining the difference in the effectiveness of ED and SSH 3%. Therefore, the purpose of this investigation is to determine whether there is a difference between the use of dexamethasone and epinephrine versus hypertonic saline (3%).
Read the detailed description
Respiratory tract infections are one of the leading causes of consultation in the Hospital General Naval de Alta Especialidad, in the emergency department and outpatient. Only in the last year (2014) shows that a total of 2690 pediatric consultations were provided in the emergency department, 1000 of them were for respiratory tract infections, constituting an approximate percentage of 37%. This figure increased over the previous year (2013) in which emergency visits corresponding 1130 290 cases consultations with boxes airways getting a percentage of 25% is given.
Due to the high incidence of lower respiratory tract infections among patients in the pediatric ward, specifically for infants under two patients; early diagnosis of acute bronchiolitis is essential to initiate proper management without falling into the overuse of drugs that have not shown adequate results.
In the last five years it has seen an increase in cases of bronchiolitis treated in both outpatient or emergency department of the Naval General Hospital. Given these data, a priority for a reason and consensus of treatment for patients with bronchiolitis.
Faced with these alarming epidemiological data both nationally and globally, it is difficult to understand that there is no consensus on the management of this entity. Although mortality is low, it represents a high cost for society and especially for health institutions, represented by a high rate of income, empirical treatments and other logistical issues.
This document intends to obtain evidence of better treatment in the population in order to establish an optimal management without spilling resources would reduce the rate of hospital admissions, first to the Naval General Hospital of High Specialty and then unify all Naval Health centers.
All this, on a solid foundation of knowledge, with the latest revisions in the interest of the subject, in order to provide the best care to every patient. Among the treatments given in this research the application of adrenaline is included, its usefulness is based on the action that causes on alpha receptors causing vasoconstriction, decreased blood flow and inflammation, responsible for the obstruction which is part of the pathophysiology of bronchiolitis. During the investigation it was decided to use it in its natural form (Levogira) because it is less expensive and the investigators can find it in an accessible at other institutions. Studies comparing its use in relation to the racemic epinephrine, show no difference. In addition to reporting a power 30 times higher in relation to the racemic epinephrine.
The study is feasible because the drugs used in this study are within the basic framework of hospital drugs, which do not involve any cost or use of additional staff for the hospital.
- Conditions
- Bronchiolitis
- Being tested
- Hypertonic Saline 3%, Epinephrine and Dexamethasone
- Keywords
- Bronchiolitis, Dexamethasone, Epinephrine, Hypertonic saline
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic Saline 3%Drug
Also called HS3%
The treatment will be administered in the following order :
First day: 3 treatments of nebulized HS 3% 3ml of treatment with interval 20 minutes Second to fourth day: One treatment of nebulized HS 3% 3ml every 24 hours .
Epinephrine and DexamethasoneDrug
Also called ED
The treatment will be administered in the following order :
First day: One treatment of nebulized dexamethasone 4mg (1ml of dexamethasone 8mg/2ml) + 3ml NS, followed by two treatments of nebulized epinephrine (3 ml of epinephrine in a 1:1000 solution per treatment) with interval 20 minutes Second to fourth day: One treatment of nebulized dexamethasone 4 mg (1ml of dexamethasone 8mg/2ml) + 3ml Normal saline 0.9%, every 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| HS3% group | Experimental | Administration of nebulized hypertonic saline for 4 days. Hypertonic Saline 3% 3 ml. Receives: Drug: Epinephrine and Dexamethasone |
| ED group | Active comparator | Administration of nebulized epinephrine and dexamethasone for 4 days. Epinephrine 1:1000 solution. Dexamethasone solution 8mg/2ml. Receives: Drug: Hypertonic Saline 3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hospital admissions
Tracking each patient until 7 days after treatment to verify hospitalization rate.
Measured: 7 days after treatment
Secondary outcomes (4)
Respiration after treatment in the First Day.
Breathing frequency after the application of nebulization in the First day of treatment (breath per minute).
Measured: 20 minutes after administration of treatment.
Heart rate after treatment in the First Day.
Heart rate after the application of nebulization in the First day of treatment (beat per minute).
Measured: 20 minutes after administration of treatment.
Diastolic and Systolic blood pressure after treatment in the First Day.
Diastolic and Systolic blood pressure after the application of nebulization in the First day of treatment (mmHg).
Measured: 20 minutes after administration of treatment.
Oxygen Saturation After after treatment in the First Day.
Oxygen Saturation after the application of nebulization in the First day of treatment (%).
Measured: 20 minutes after administration of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionFeb 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Naval de Alta Especialidad - Escuela Medico Naval
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Dra. Mayra Rubi Arcos Cruz, Pediatrician, Principal investigator, Secretaria de Marina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585531
- Sponsor's protocol ID
- HGNAE 06
- Status last verified
- Oct 2015
- First submitted
- 13 Oct 2015
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nebot MS, Teruel GC, Cubells CL, Sabadell MD, Fernandez JP. [Acute bronchiolitis clinical practice guideline: recommendations for clinical practice]. An Pediatr (Barc). 2010 Oct;73(4):208.e1-10. doi: 10.1016/j.anpedi.2010.04.015. Epub 2010 Jul 14. Spanish.
PubMed 20634158Zorc JJ, Hall CB. Bronchiolitis: recent evidence on diagnosis and management. Pediatrics. 2010 Feb;125(2):342-9. doi: 10.1542/peds.2009-2092. Epub 2010 Jan 25.
PubMed 20100768Corneli HM, Zorc JJ, Holubkov R, Bregstein JS, Brown KM, Mahajan P, Kuppermann N; Bronchiolitis Study Group for the Pediatric Emergency Care Applied Research Network. Bronchiolitis: clinical characteristics associated with hospitalization and length of stay. Pediatr Emerg Care. 2012 Feb;28(2):99-103. doi: 10.1097/PEC.0b013e3182440b9b.
PubMed 22270499Vinci R, Bauchner H. Bronchiolitis, deception in research, and clinical decision making. JAMA. 2014 Aug 20;312(7):699-700. doi: 10.1001/jama.2014.8638. No abstract available.
PubMed 25138330Acosta A et all. Diagnóstico y manejo en niños con Bronquiolitis en fase aguda, México: Secretaria de Salud. Catálogo Maestro de Guías de práctica clínica IMSS-032-08. 2010.
Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742.
PubMed 25349312Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11.
PubMed 22579125Koehoorn M, Karr CJ, Demers PA, Lencar C, Tamburic L, Brauer M. Descriptive epidemiological features of bronchiolitis in a population-based cohort. Pediatrics. 2008 Dec;122(6):1196-203. doi: 10.1542/peds.2007-2231.
PubMed 19047234Baraldi E, Lanari M, Manzoni P, Rossi GA, Vandini S, Rimini A, Romagnoli C, Colonna P, Biondi A, Biban P, Chiamenti G, Bernardini R, Picca M, Cappa M, Magazzu G, Catassi C, Urbino AF, Memo L, Donzelli G, Minetti C, Paravati F, Di Mauro G, Festini F, Esposito S, Corsello G. Inter-society consensus document on treatment and prevention of bronchiolitis in newborns and infants. Ital J Pediatr. 2014 Oct 24;40:65. doi: 10.1186/1824-7288-40-65.
PubMed 25344148Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, Chandran A, Theodoratou E, Sutanto A, Sedyaningsih ER, Ngama M, Munywoki PK, Kartasasmita C, Simoes EA, Rudan I, Weber MW, Campbell H. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010 May 1;375(9725):1545-55. doi: 10.1016/S0140-6736(10)60206-1.
PubMed 20399493Ochoa Sangrador C, Gonzalez de Dios J; Grupo Investigador del Proyecto aBREVIADo (BRonquiolitis-Estudio de Variabilidad, Idoneidad y ADecuacion). [Management of acute bronchiolitis in spanish emergency wards: variability and appropriateness analysis (aBREVIADo project)]. An Pediatr (Barc). 2013 Sep;79(3):167-76. doi: 10.1016/j.anpedi.2013.01.015. Epub 2013 Mar 6. Spanish.
PubMed 23481463Yusuf S, Caviness AC, Adekunle-Ojo AO. Risk factors for admission in children with bronchiolitis from pediatric emergency department observation unit. Pediatr Emerg Care. 2012 Nov;28(11):1132-5. doi: 10.1097/PEC.0b013e31827132ff.
PubMed 23114233Ipek IO, Yalcin EU, Sezer RG, Bozaykut A. The efficacy of nebulized salbutamol, hypertonic saline and salbutamol/hypertonic saline combination in moderate bronchiolitis. Pulm Pharmacol Ther. 2011 Dec;24(6):633-7. doi: 10.1016/j.pupt.2011.09.004. Epub 2011 Sep 29.
PubMed 21978929Ralston S, Garber M, Narang S, Shen M, Pate B, Pope J, Lossius M, Croland T, Bennett J, Jewell J, Krugman S, Robbins E, Nazif J, Liewehr S, Miller A, Marks M, Pappas R, Pardue J, Quinonez R, Fine BR, Ryan M. Decreasing unnecessary utilization in acute bronchiolitis care: results from the value in inpatient pediatrics network. J Hosp Med. 2013 Jan;8(1):25-30. doi: 10.1002/jhm.1982. Epub 2012 Oct 9.
PubMed 23047831Plint AC, Johnson DW, Patel H, Wiebe N, Correll R, Brant R, Mitton C, Gouin S, Bhatt M, Joubert G, Black KJ, Turner T, Whitehouse S, Klassen TP; Pediatric Emergency Research Canada (PERC). Epinephrine and dexamethasone in children with bronchiolitis. N Engl J Med. 2009 May 14;360(20):2079-89. doi: 10.1056/NEJMoa0900544.
PubMed 19439742
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epinephrine, Dexamethasone, and Hypertonic Saline in Children With Bronchiolitis in the Hospital General Naval de Alta Especialidad. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02585531
- Acronym / sponsor ID
- HGNAE 06
- Conditions
- Bronchiolitis
- Keywords
- Bronchiolitis, Dexamethasone, Epinephrine, Hypertonic saline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital General Naval de Alta Especialidad - Escuela Medico NavalOther government
- Study start
- Nov 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 23 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bronchiolitis is one of the main reasons for consultation in primary care and emergency services, as well as the leading cause of hospitalization for lower respiratory tract infection in children under two years. There is still no consensus on the medical management of the disease, in clinical practice there is wide variability in the treatment with inhaled drugs and / or oral bronchodilators, steroids, antihistamines despite the viral etiology of the disease, which results in increased morbidity and a major economic benefit for all health services.
Several studies are in relation to the management of bronchiolitis, one of which was made during 2014 in the Naval Hospital of High Specialty which included 90 participants comparing 3 treatment. The treatments administered were: dexamethasone and epinephrine (Levogira) (ED), hypertonic saline 3% (SSH 3%)and saline 0.9% ( SS 0.9%), finding that the handling of ED and SSH 3% had lower rates of hospital admissions compared to the symptomatic management of SS 0.9%. Although the superiority of SSH3% and ED in relation to the use of SS 0.9% was demonstrated, it was not possible to establish difference statistically significant between them. Why it was considered necessary to continue the study focused on determining the difference in the effectiveness of ED and SSH 3%. Therefore, the purpose of this investigation is to determine whether there is a difference between the use of dexamethasone and epinephrine versus hypertonic saline (3%).
Detailed description
Respiratory tract infections are one of the leading causes of consultation in the Hospital General Naval de Alta Especialidad, in the emergency department and outpatient. Only in the last year (2014) shows that a total of 2690 pediatric consultations were provided in the emergency department, 1000 of them were for respiratory tract infections, constituting an approximate percentage of 37%. This figure increased over the previous year (2013) in which emergency visits corresponding 1130 290 cases consultations with boxes airways getting a percentage of 25% is given.
Due to the high incidence of lower respiratory tract infections among patients in the pediatric ward, specifically for infants under two patients; early diagnosis of acute bronchiolitis is essential to initiate proper management without falling into the overuse of drugs that have not shown adequate results.
In the last five years it has seen an increase in cases of bronchiolitis treated in both outpatient or emergency department of the Naval General Hospital. Given these data, a priority for a reason and consensus of treatment for patients with bronchiolitis.
Faced with these alarming epidemiological data both nationally and globally, it is difficult to understand that there is no consensus on the management of this entity. Although mortality is low, it represents a high cost for society and especially for health institutions, represented by a high rate of income, empirical treatments and other logistical issues.
This document intends to obtain evidence of better treatment in the population in order to establish an optimal management without spilling resources would reduce the rate of hospital admissions, first to the Naval General Hospital of High Specialty and then unify all Naval Health centers.
All this, on a solid foundation of knowledge, with the latest revisions in the interest of the subject, in order to provide the best care to every patient. Among the treatments given in this research the application of adrenaline is included, its usefulness is based on the action that causes on alpha receptors causing vasoconstriction, decreased blood flow and inflammation, responsible for the obstruction which is part of the pathophysiology of bronchiolitis. During the investigation it was decided to use it in its natural form (Levogira) because it is less expensive and the investigators can find it in an accessible at other institutions. Studies comparing its use in relation to the racemic epinephrine, show no difference. In addition to reporting a power 30 times higher in relation to the racemic epinephrine.
The study is feasible because the drugs used in this study are within the basic framework of hospital drugs, which do not involve any cost or use of additional staff for the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS3% group | Experimental | Drug: Epinephrine and DexamethasoneAdministration of nebulized hypertonic saline for 4 days. Hypertonic Saline 3% 3 ml. |
| ED group | Active comparator | Drug: Hypertonic Saline 3%Administration of nebulized epinephrine and dexamethasone for 4 days. Epinephrine 1:1000 solution. Dexamethasone solution 8mg/2ml. |
Who may qualify
- Ages
- 2 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients under 2 years of age diagnosed with bronchiolitis
- Be beneficiaries Marine
- Outpatient
- Severity of Bronchiolitis mild to moderate scale according to Difficulty rating scale Respiratory (RDAI) for bronchiolitis (RDAI score 2-8).
Key exclusion criteria (4 listed)
- Patients with a history of atopy
- Patients with a history of asthma in infants.
- Patients with comorbidity
- RDAI> 9 at diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypertonic Saline 3%Also: HS3%The treatment will be administered in the following order : First day: 3 treatments of nebulized HS 3% 3ml of treatment with interval 20 minutes Second to fourth day: One treatment of nebulized HS 3% 3ml every 24 hours . | Drug | ED group |
| Epinephrine and DexamethasoneAlso: EDThe treatment will be administered in the following order : First day: One treatment of nebulized dexamethasone 4mg (1ml of dexamethasone 8mg/2ml) + 3ml NS, followed by two treatments of nebulized epinephrine (3 ml of epinephrine in a 1:1000 solution per treatment) with interval 20 minutes Second to fourth day: One treatment of nebulized dexamethasone 4 mg (1ml of dexamethasone 8mg/2ml) + 3ml Normal saline 0.9%, every 24 hours. | Drug | HS3% group |
Primary outcome
Rate of hospital admissions
Time frame: 7 days after treatment
Tracking each patient until 7 days after treatment to verify hospitalization rate.
4 secondary outcomes
Respiration after treatment in the First Day.
Time frame: 20 minutes after administration of treatment.
Heart rate after treatment in the First Day.
Time frame: 20 minutes after administration of treatment.
Diastolic and Systolic blood pressure after treatment in the First Day.
Time frame: 20 minutes after administration of treatment.
Oxygen Saturation After after treatment in the First Day.
Time frame: 20 minutes after administration of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2015.
- Results publication: PubMed 20634158Nebot MS, Teruel GC, Cubells CL, Sabadell MD, Fernandez JP. [Acute bronchiolitis clinical practice guideline: recommendations for clinical practice]. An Pediatr (Barc). 2010 Oct;73(4):208.e1-10. doi: 10.1016/j.anpedi.2010.04.015. Epub 2010 Jul 14. Spanish.
- Results publication: PubMed 20100768Zorc JJ, Hall CB. Bronchiolitis: recent evidence on diagnosis and management. Pediatrics. 2010 Feb;125(2):342-9. doi: 10.1542/peds.2009-2092. Epub 2010 Jan 25.
- Results publication: PubMed 22270499Corneli HM, Zorc JJ, Holubkov R, Bregstein JS, Brown KM, Mahajan P, Kuppermann N; Bronchiolitis Study Group for the Pediatric Emergency Care Applied Research Network. Bronchiolitis: clinical characteristics associated with hospitalization and length of stay. Pediatr Emerg Care. 2012 Feb;28(2):99-103. doi: 10.1097/PEC.0b013e3182440b9b.
- Results publication: PubMed 25138330Vinci R, Bauchner H. Bronchiolitis, deception in research, and clinical decision making. JAMA. 2014 Aug 20;312(7):699-700. doi: 10.1001/jama.2014.8638. No abstract available.
- Results publicationAcosta A et all. Diagnóstico y manejo en niños con Bronquiolitis en fase aguda, México: Secretaria de Salud. Catálogo Maestro de Guías de práctica clínica IMSS-032-08. 2010.
- Results publication: PubMed 25349312Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742.
- Results publication: PubMed 22579125Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11.
- Results publication: PubMed 19047234Koehoorn M, Karr CJ, Demers PA, Lencar C, Tamburic L, Brauer M. Descriptive epidemiological features of bronchiolitis in a population-based cohort. Pediatrics. 2008 Dec;122(6):1196-203. doi: 10.1542/peds.2007-2231.
- Results publication: PubMed 25344148Baraldi E, Lanari M, Manzoni P, Rossi GA, Vandini S, Rimini A, Romagnoli C, Colonna P, Biondi A, Biban P, Chiamenti G, Bernardini R, Picca M, Cappa M, Magazzu G, Catassi C, Urbino AF, Memo L, Donzelli G, Minetti C, Paravati F, Di Mauro G, Festini F, Esposito S, Corsello G. Inter-society consensus document on treatment and prevention of bronchiolitis in newborns and infants. Ital J Pediatr. 2014 Oct 24;40:65. doi: 10.1186/1824-7288-40-65.
- Results publication: PubMed 20399493Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, Chandran A, Theodoratou E, Sutanto A, Sedyaningsih ER, Ngama M, Munywoki PK, Kartasasmita C, Simoes EA, Rudan I, Weber MW, Campbell H. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010 May 1;375(9725):1545-55. doi: 10.1016/S0140-6736(10)60206-1.
- Results publication: PubMed 23481463Ochoa Sangrador C, Gonzalez de Dios J; Grupo Investigador del Proyecto aBREVIADo (BRonquiolitis-Estudio de Variabilidad, Idoneidad y ADecuacion). [Management of acute bronchiolitis in spanish emergency wards: variability and appropriateness analysis (aBREVIADo project)]. An Pediatr (Barc). 2013 Sep;79(3):167-76. doi: 10.1016/j.anpedi.2013.01.015. Epub 2013 Mar 6. Spanish.
- Results publication: PubMed 23114233Yusuf S, Caviness AC, Adekunle-Ojo AO. Risk factors for admission in children with bronchiolitis from pediatric emergency department observation unit. Pediatr Emerg Care. 2012 Nov;28(11):1132-5. doi: 10.1097/PEC.0b013e31827132ff.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dra. Mayra Rubi Arcos Cruz, Pediatrician principal investigator
Secretaria de Marina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypertonic Saline 3% and Epinephrine and Dexamethasone in people with Bronchiolitis, run by Hospital General Naval de Alta Especialidad - Escuela Medico Naval at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dra. Mayra Rubí Arcos Cruz, Pediatrician ((52) 55-28-300-519, may03_05@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of hospital admissions (time frame: 7 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02585531, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2015.