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Epinephrine, Dexamethasone and Hypertonic Saline in Bronchiolitis

NCT02585531 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-11-11

No results posted yet for this study

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

Interventions

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 .

DRUG

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.

Sponsors & Collaborators

  • Hospital General Naval de Alta Especialidad - Escuela Medico Naval

    lead OTHER_GOV

Principal Investigators

  • Dra. Mayra Rubi Arcos Cruz, Pediatrician · Secretaria de Marina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-02-28
Completion
2017-04-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02585531 on ClinicalTrials.gov