Epinephrine, Dexamethasone and Hypertonic Saline in Bronchiolitis

Bronchiolitis Clinical Trial

Official title:

Epinephrine, Dexamethasone, and Hypertonic Saline in Children With Bronchiolitis in the Hospital General Naval de Alta Especialidad. A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02585531
• Other study ID #: HGNAE 06
• Status: Not yet recruiting
• Phase: Phase 2
• First received: October 13, 2015
• Last updated: November 10, 2015
• Start date: November 2015
• Est. completion date: April 2017

Study information

• Verified date: October 2015
• Source: Hospital General Naval de Alta Especialidad - Escuela Medico Naval
• Contact: Dra. Mayra Rubí Arcos Cruz, Pediatrician
• Phone: (52) 55-28-300-519
• Email: may03_05[@]hotmail.com
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical 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. 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%).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 24 Months

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• Patients with a history of atopy

• Patients with a history of asthma in infants.

• Patients with comorbidity

• RDAI> 9 at diagnosis.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Drug:
• Hypertonic Saline 3%
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 Dexamethasone
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.

Locations

Country	Name	City	State
Mexico	Hospital General Naval de Alta Especialidad	México, Distrito Federal	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Country where clinical trial is conducted

Mexico, 

References & Publications (18)

Acosta 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.

Baraldi 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, Magazzù G, Catassi C, Urbino AF, Memo L, Donzelli G, Minetti C, Paravati F, Di Mauro G, Festini F, Espos — View Citation

Brand PL, Baraldi E, Bisgaard H, Boner AL, Castro-Rodriguez JA, Custovic A, de Blic J, de Jongste JC, Eber E, Everard ML, Frey U, Gappa M, Garcia-Marcos L, Grigg J, Lenney W, Le Souëf P, McKenzie S, Merkus PJ, Midulla F, Paton JY, Piacentini G, Pohunek P, — View Citation

Corneli 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 st — View Citation

Hartling L, Fernandes RM, Bialy L, Milne A, Johnson D, Plint A, Klassen TP, Vandermeer B. Steroids and bronchodilators for acute bronchiolitis in the first two years of life: systematic review and meta-analysis. BMJ. 2011 Apr 6;342:d1714. doi: 10.1136/bmj — View Citation

Ipek 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 — View Citation

Koehoorn 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. — View Citation

Liu 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 systema — View Citation

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Nair 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, Simões EA, Rudan I, Weber MW, Campbell H. Global burden o — View Citation

Nebot MS, Teruel GC, Cubells CL, Sabadell MD, Fernández 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 — View Citation

Ochoa Sangrador C, González de Dios J; Grupo Investigador del Proyecto aBREVIADo (BRonquiolitis-Estudio de Variabilidad, Idoneidad y ADecuación). [Management of acute bronchiolitis in spanish emergency wards: variability and appropriateness analysis (aBRE — View Citation

Plint 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 En — View Citation

Ralston 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 bro — View Citation

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 Pediatri — View Citation

Vinci 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. — View Citation

Yusuf 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. — View Citation

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of hospital admissions	Tracking each patient until 7 days after treatment to verify hospitalization rate.	7 days after treatment	Yes
Secondary	Respiration after treatment in the First Day.	Breathing frequency after the application of nebulization in the First day of treatment (breath per minute).	20 minutes after administration of treatment.	Yes
Secondary	Heart rate after treatment in the First Day.	Heart rate after the application of nebulization in the First day of treatment (beat per minute).	20 minutes after administration of treatment.	Yes
Secondary	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).	20 minutes after administration of treatment.	Yes
Secondary	Oxygen Saturation After after treatment in the First Day.	Oxygen Saturation after the application of nebulization in the First day of treatment (%).	20 minutes after administration of treatment.	Yes