High Flow Therapy vs Hypertonic Saline in Bronchiolitis

Ministry of Health, Spain

Status and phase: Completed; Phase 3

Conditions: Acute Viral Bronchiolitis

Treatments: Device: HHHFNC; Drug: Epinephrine 1/1000; Drug: HSS 3%; Drug: NS (0.9%)

Study type: Interventional

Funder types: Other

Identifiers

NCT01873144

EC11-437

Details and patient eligibility

About

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).

Enrollment: 75 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children aged 6 months or less
• Moderate (Respiratory Distress Assessment Instrument score of 4 or greater) viral bronchiolitis (as defined by McConnockie)
• Meeting Admission criteria

Exclusion criteria

• History of prematurity
• Chronic lung disease
• Cystic fibrosis
• Congenital heart disease
• Neuromuscular disease
• Airway anomalies
• Immunodeficiency
• Those requiring immediate intubation and ventilation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

75 participants in 2 patient groups

HSS (3%) + epinephrine

Active Comparator group

Description:

Nebulized solution containing 0.5 mL/kg (maximum 3 mL) of epinephrine 1/1000 plus 2 mL of HSS(3%) every 4h for three times and afterwards at physician in charge criteria.

Treatment:

Drug: HSS 3%

Drug: Epinephrine 1/1000

HHHFNC+epinephrine+Normal Saline(0.9%)

Experimental group

Description:

Flow depending on weight (Tidal volume x respiratory rate x 9) and nebulized solution containing 0.5 mL/kg (maximum 3 mL) of epinephrine 1/1000 plus 2 mL of Normal Saline (NS) (0.9%) every 4h and afterwards at physician in charge criteria.

Treatment:

Drug: NS (0.9%)

Device: HHHFNC

Drug: Epinephrine 1/1000