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High Flow Therapy vs Hypertonic Saline in Bronchiolitis

NCT01873144 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2013-06-07

No results posted yet for this study

Summary

The purpose of this study is to demonstrate that heated, humidified, high-flow nasal cannula (HHHFNC) is superior to hypertonic saline solution (HSS) in the treatment of moderate acute viral bronchiolitis in infants in improving respiratory distress and comfort and reducing length of hospital stay (LOS) and admission to Pediatric Intensive Care Unit (PICU).

Conditions

  • Acute Viral Bronchiolitis

Interventions

DRUG

Epinephrine 1/1000

Nebulization of 0.5 mL/kg (maximum 3 mL) of epinephrine 1/1000 every 4h for three times and afterwards at physician in charge criteria

DRUG

HSS 3%

Nebulization 2 mL of HSS (3%)+ epinephrine every 4h for three times and afterwards at physician in charge criteria

DEVICE

HHHFNC

Precision Flow (Vapotherm Inc. Stevensville, Maryland, US ) and RT329 (Fisher and Paykel Healthcare, Auckland, New Zealand) were the dispositive used depending on the availability. Fisher and Paykel nasal cannula was used in both devices, depending on age

DRUG

NS (0.9%)

Nebulization of 2 mL of NS (0.9%)+ epinephrine every 4h for three times and afterwards at physician in charge criteria

Sponsors & Collaborators

  • Ministry of Health, Spain

    lead OTHER_GOV

Principal Investigators

  • Mercedes Bueno, MD · Department of Pediatrics and Neonatology. Hospital Universitario Fundacion Alcorcon. Madrid. SPAIN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Spain

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 NCT01873144 on ClinicalTrials.gov