NCT01873144

High Flow Therapy vs Hypertonic Saline in Bronchiolitis

High Flow Therapy vs Hypertonic Saline in Bronchiolitis Treatment. Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Ministry of Health, Spain · Other Government
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2013-06-07
• Last updated: 2013-06-07

Locations

2 sites across 1 country: Spain