7% Hypertonic Saline for Acute Bronchiolitis

NCT01871857 | Completed Phase 4 DMC

• 1 other identifier: LCH
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Research suggests that hypertonic saline may improve mucous flow in infants with acute bronchiolitis. Data suggest a trend favoring reduced length of hospital stay and improved pulmonary scores with increasing concentration of nebulized solution to 3% and 5% saline as compared to 0.9% saline mixed with epinephrine. To our knowledge, 7% hypertonic saline has not been previously investigated. OUr hypothesis was that 7% hypertonic saline would improve bronchiolitis severity scores and admission rate.

Conditions

Acute Bronchiolitis

Outcome Measures

Primary Outcomes (1)

• Change in Bronchiolitis Severity Score

  Bronchiolitis severity scores were recorded prior to administering aerosols, after administering the aerosol, and again once the treating clinician determined the final disposition of the patient. After a 4-h observation period, the treating clinician determined patient disposition. If admitted, the patient continued to receive aerosols containing the same designated medication every 6 h until discharge or 24 h after the admission. Bronchiolitis severity scores were obtained before and after each treatment.

  Baseline and up to 24 hours of hospital stay

Secondary Outcomes (1)

• Admission rate

  For approximately 2 yrs, the duration of the study

Study Arms (2)

Normal saline and epinephrine

ACTIVE COMPARATOR

0.9 % saline with 0.5 ml of 1:1000 epinephrine inhalation

Drug: Normal saline and epinephrine

Hypertonic saline and epinephrine

EXPERIMENTAL

3 ml 7% saline with 0.5 ml of 1:1000 epinephrine inhalation

Drug: Hypertonic saline and epinephrine

Interventions

Hypertonic saline and epinephrine DRUG

Hypertonic saline and epinephrine

Normal saline and epinephrine DRUG

Normal saline and epinephrine

Eligibility Criteria

• Age: 6 Weeks - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients age 6 weeks to ≤ 18 months
• Diagnosed with bronchiolitis (defined as viral respiratory illness and first episode of wheeze)
• BSS score of ≥ 4

You may not qualify if:

• A previous history of wheezing;
• diagnosis of asthma;
• any use of bronchodilators within 2 h of presentation
• gestational age ≤ 34 weeks
• history of congenital heart disease
• chronic pulmonary or chronic renal disease
• oxygen saturation of ≤ 85% at the time of recruitment
• severe disease requiring intensive care unit admission
• inability to obtain informed consent

Sponsors & Collaborators

• Le Bonheur Children's Hospital: lead

Study Sites (1)

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

Location

Related Publications (1)

• Jacobs JD, Foster M, Wan J, Pershad J. 7% Hypertonic saline in acute bronchiolitis: a randomized controlled trial. Pediatrics. 2014 Jan;133(1):e8-13. doi: 10.1542/peds.2013-1646. Epub 2013 Dec 16.

  PMID: 24344111 DERIVED

MeSH Terms

Interventions

Saline Solution, Hypertonic; Epinephrine; Saline Solution

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions

Study Officials

• Jay Pershad, MD

  Le Bonheur Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Emergency Physician

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 7, 2013
• Study Start: November 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 11, 2013

Record last verified: 2013-06

Locations

US (1)