Epinephrine, Dexamethasone and Hypertonic Saline in Bronchiolitis

NCT02585531 | Unknown Phase 2

• 1 other identifier: HGNAE 06
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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%).

Conditions

Bronchiolitis

Keywords

Bronchiolitis; Dexamethasone; Epinephrine; Hypertonic saline

Outcome Measures

Primary Outcomes (1)

• Rate of hospital admissions

  Tracking each patient until 7 days after treatment to verify hospitalization rate.

  7 days after treatment

Secondary Outcomes (4)

• Respiration after treatment in the First Day.

  20 minutes after administration of treatment.

• Heart rate after treatment in the First Day.

  20 minutes after administration of treatment.

• Diastolic and Systolic blood pressure after treatment in the First Day.

  20 minutes after administration of treatment.

• Oxygen Saturation After after treatment in the First Day.

  20 minutes after administration of treatment.

Study Arms (2)

HS3% group

EXPERIMENTAL

Administration of nebulized hypertonic saline for 4 days. Hypertonic Saline 3% 3 ml.

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.

Drug: Hypertonic Saline 3%

Interventions

Hypertonic Saline 3% DRUG

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 .

Also known as: HS3%

ED group

Epinephrine and Dexamethasone DRUG

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.

Also known as: ED

HS3% group

Eligibility Criteria

• Age: 2 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Patients with a history of atopy
• Patients with a history of asthma in infants.
• Patients with comorbidity
• RDAI\> 9 at diagnosis.

Sponsors & Collaborators

• Hospital General Naval de Alta Especialidad - Escuela Medico Naval: lead

Study Sites (1)

Hospital General Naval de Alta Especialidad

Mexico City, Mexico City, 04480, Mexico

Location

Related Publications (18)

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MeSH Terms

Conditions

Bronchiolitis

Interventions

Epinephrine; Dexamethasone

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Dra. Mayra Rubi Arcos Cruz, Pediatrician

  Secretaria de Marina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dra. Mayra Rubí Arcos Cruz, Pediatrician

CONTACT

(52) 55-28-300-519; may03_05@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 23, 2015
• Study Start: November 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: April 1, 2017
• Last Updated: November 11, 2015

Record last verified: 2015-10

Locations

ME (1)