7% Hypertonic Saline for Acute Bronchiolitis (HS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jonathan Jacobs, Le Bonheur Children's Hospital
ClinicalTrials.gov Identifier:
NCT01871857
First received: May 29, 2013
Last updated: June 8, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Acute Bronchiolitis
Drug: Hypertonic saline and epinephrine
Drug: Normal saline and epinephrine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 7% Hypertonic Saline for Acute Bronchiolitis: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Le Bonheur Children's Hospital:

Primary Outcome Measures:
  • Change in Bronchiolitis Severity Score [ Time Frame: Baseline and up to 24 hours of hospital stay ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Admission rate [ Time Frame: For approximately 2 yrs, the duration of the study ] [ Designated as safety issue: No ]
    Secondary outcome measures included hospitalization rate, discharge rate at 23 h (observation status), and length of hospital stay. These are a composite of measures reflecting impact of hypertonic saline on in-patient metrics


Enrollment: 101
Study Start Date: November 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Normal saline and epinephrine
0.9 % saline with 0.5 ml of 1:1000 epinephrine inhalation
Drug: Normal saline and epinephrine
Experimental: Hypertonic saline and epinephrine
3 ml 7% saline with 0.5 ml of 1:1000 epinephrine inhalation
Drug: Hypertonic saline and epinephrine

Detailed Description:

Study design A double-blinded, randomized, comparative, controlled trial was conducted in the ED of an urban tertiary care center, with an annual census of 70,000 patient visits. The Institutional Review Board approved the study.

Patient selection Informed consent was obtained from a parent or legal guardian of each patient enrolled in the study. Patients age 6 weeks to ≤ 18 months presenting to the ED between October and March over a 2-year period (2010-2012) with bronchiolitis (defined as viral respiratory illness and first episode of wheeze) and a BSS score of ≥ 4 were eligible for the study. Exclusion criteria were 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, or inability to obtain informed consent. Depending on the availability of the principal investigator (a pediatric emergency medicine fellow), a convenience sample was used to recruit patients. The ED physicians and staff were notified of the fellow's hours of availability by way of a call schedule that was posted in the ED.

Study protocol Eligible patients were randomized to one of two groups in blocks of 10. The control group received an aerosol of 0.5 ml of 2.25% racemic epinephrine with 3 ml of 0.9% saline, and the study group received 0.5 ml of 2.25% racemic epinephrine with 3 ml of 7% HS.

The treating clinician in the ED contacted the principal investigator within an hour of an eligible patient's arrival. The pharmacy department maintained a box in the ED holding sequentially numbered, previously randomized concealed envelopes containing either the study (7% HS) or control (0.9% saline) medication. After initial screening and assessment and after consent was obtained, the patient was administered the medication via nebulization driven by 6 L/min O2 flow. Research personnel, the treating physician, and staff who performed the BSS were kept blinded throughout the process. 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. A standardized data sheet was completed after enrollment and during each patient's stay in the ED or inpatient ward. Any co-interventions such as additional bronchodilators, supplemental oxygen, intravenous fluids, or deep nasal suction were at the discretion of the treating clinician. The clinician was free to withdraw the patient from the study if clinical deterioration warranted escalation of care or if adverse effects related to the medication were observed.

Outcome measures The BSS is an objective respiratory assessment tool that has been previously validated (Table 1).14 We used a modified BSS, which is used in our institution since 2006, to assess severity of illness in acute bronchiolitis. (Table 2) A change in the modified BSS was the primary outcome.

  Eligibility

Ages Eligible for Study:   6 Weeks to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01871857

Locations
United States, Tennessee
Le Bonheur Children's Hospital
Memphis, Tennessee, United States, 38103
Sponsors and Collaborators
Le Bonheur Children's Hospital
Investigators
Study Director: Jay Pershad, MD Le Bonheur Children's Hospital
  More Information

No publications provided by Le Bonheur Children's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonathan Jacobs, Pediatric Emergency Physician, Le Bonheur Children's Hospital
ClinicalTrials.gov Identifier: NCT01871857     History of Changes
Other Study ID Numbers: LCH
Study First Received: May 29, 2013
Last Updated: June 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014