Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis

The University of Texas System (UT)

Status: Completed

Conditions: Acute Bronchiolitis

Treatments: Drug: 3% Hypertonic Saline; Drug: 0.9 % normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02029040

STU 012013-040

Details and patient eligibility

About

This is a randomized, double-blind, controlled trial in the Pediatric Emergency Department. The primary objective is to determine whether nebulized 3% hypertonic saline is more effective than nebulized 0.9% saline in the treatment of bronchiolitis in the emergency department.

Enrollment: 52 patients

Sex: All

Ages: 2 to 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children 2-12 months of age presenting to Emergency Department
• Patients with a diagnosis of bronchiolitis defined as the first episode of wheezing and/or crackles in a child younger than 12 months who has physical findings of a viral respiratory infection and has no other explanation for the wheezing and/or crackles
• Patients with an RDAI score ≥ 6 as measured by a trained respiratory therapist

Exclusion criteria

• Previous history of wheezing
• Known heart or lung disease
• Premature birth defined as birth before 37 weeks gestation
• Immunosuppression or immunodeficiency
• Treatment with corticosteroids in the previous 48 hours
• Critically ill children - progressive respiratory failure requiring higher level of care, vital signs instability/need for emergency interventions to prevent clinical deterioration
• Oxygen saturation <85% on room air at the time of recruitment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

3% hypertonic saline group

Experimental group

Description:

Once consented, the study drug (in this arm: 3% Hypertonic Saline) will be ordered by a physician at the request of a study team member. Once the drug order set is received by a pharmacist, he/she will obtain the study drug from an Omnicell and prepare the medication to a volume of 3 mL in a syringe with a blinded study label prepared in advance by the IDS pharmacy. The pharmacist will then give the study drug to the patient's respiratory therapist or the bedside nurse. The respiratory therapist or the nurse will pour the drug from a syringe to an inhaler cup and the study drug will be given by the standard nebulizer over the course of 15 minutes.

Treatment:

Drug: 3% Hypertonic Saline

0.9% normal saline group

Placebo Comparator group

Description:

Once consented, the study drug (in this arm: 0.9% normal saline) will be ordered by a physician at the request of a study team member. Once the drug order set is received by a pharmacist, he/she will obtain the study drug from an Omnicell and prepare the medication to a volume of 3 mL in a syringe with a blinded study label prepared in advance by the IDS pharmacy. The pharmacist will then give the study drug to the patient's respiratory therapist or the bedside nurse. The respiratory therapist or the nurse will pour the drug from a syringe to an inhaler cup and the study drug will be given by the standard nebulizer over the course of 15 minutes.

Treatment:

Drug: 0.9 % normal saline