Nebulized 5% Hypertonic Saline for the Treatment of Bronchiolitis

NCT01016249 | Completed Phase 4

• 1 other identifier: #7055
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators reasoned that a hypertonic saline concentration higher than 3% could be safe and more efficacious in the treatment of bronchiolitis, alleviating severe symptoms and preventing the need for hospitalization in some instances.

Conditions

Bronchiolitis

Keywords

Bronchiolitis, Viral; An acute inflammation of the upper RESPIRATORY TRACT

Outcome Measures

Primary Outcomes (1)

• Mean pre-nebulization bronchiolitis severity score for each treatment group at 48 hours

  2 years

Secondary Outcomes (1)

• The treatments' severity scores at 24 hours and trend over time to 72 hours, 2 hours-post-nebulization severity scores trending over time, as well as safety measures

  2 years

Study Arms (3)

Treatment 1. 5% Saline + Epinephrine

ACTIVE COMPARATOR

Nebulization with 4ml of 5% saline mixed with 1.5 ml of epinephrine every 4 hours thereafter until ready for discharge. Immediately before nebulization, just after, and 2 hours after, the following measurements were collected for each patients: bronchiolitis severity score, oxygen saturation on room air, and heart rate.

Drug: Treatment 1. (5% Hypertonic saline + Epinephrine)

Treatment 3. 3% Saline + Epinephrine

OTHER

Nebulization with 4ml of 3% saline mixed with 1.5 ml of epinephrine every 4 hours thereafter until ready for discharge. Immediately before nebulization, just after, and 2 hours after, the following measurements were collected for each patients: bronchiolitis severity score, oxygen saturation on room air, and heart rate.

Drug: Treatment 3. (3% Hypertonic saline + Epinephrine)

Treatment 2 . 0.9% Saline + Epinephrine

OTHER

Nebulization with 4ml of 0.9% saline mixed with 1.5 ml of epinephrine every 4 hours thereafter until ready for discharge. Immediately before nebulization, just after, and 2 hours after, the following measurements were collected for each patients: bronchiolitis severity score, oxygen saturation on room air, and heart rate.

Drug: Treatment 2. (Normal saline + Epinephrine)

Interventions

Treatment 1. (5% Hypertonic saline + Epinephrine) DRUG

Nebulization of 4ml 5% saline mixed with 1.5 ml of epinephrine on enrollment and every 4 hours thereafter until ready for discharge.

Also known as: 5% Hypertonic saline

Treatment 1. 5% Saline + Epinephrine

Treatment 3. (3% Hypertonic saline + Epinephrine) DRUG

Nebulization of 4ml 3% saline mixed with 1.5 ml of epinephrine on enrollment and every 4 hours thereafter until ready for discharge.

Also known as: 3% Hypertonic saline

Treatment 3. 3% Saline + Epinephrine

Treatment 2. (Normal saline + Epinephrine) DRUG

Nebulization of 4ml 0.9% saline mixed with 1.5 ml of epinephrine on enrollment and every 4 hours thereafter until ready for discharge.

Also known as: Normal saline

Treatment 2 . 0.9% Saline + Epinephrine

Eligibility Criteria

• Age: 1 Day - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants aged ≤ 18 months presenting to the unit for the treatment of moderate-severe viral bronchiolitis were eligible for the study.
• Moderate-severe bronchiolitis required having a prodromal history consistent with viral upper respiratory tract infection followed by wheezing and/or crackles on auscultation and a Wang bronchiolitis severity score of ≥ 4 on presentation.

You may not qualify if:

• Patients were excluded from the study if they had one or more of the following characteristics:
• Born preterm ≤ 34 weeks gestation,
• Previous history of wheezing,
• Steroid use within 48 hours of presentation,
• Obtundation and progressive respiratory failure requiring ICU admission,
• History of apnea with in 24 hours before presentation,
• Oxygen saturation ≤ 85% on room air at the time of recruitment,
• History of a diagnosis of chronic lung disease,
• Congenital heart disease, or
• Immunodeficiency.

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Pediatric Emergency Center, Al-Saad

Doha, Baladīyat ad Dawḩah, 3050, Qatar

Location

Related Publications (1)

• Al-Ansari K, Sakran M, Davidson BL, El Sayyed R, Mahjoub H, Ibrahim K. Nebulized 5% or 3% hypertonic or 0.9% saline for treating acute bronchiolitis in infants. J Pediatr. 2010 Oct;157(4):630-4, 634.e1. doi: 10.1016/j.jpeds.2010.04.074. Epub 2010 Jun 19.

  PMID: 20646715 DERIVED

MeSH Terms

Conditions

Bronchiolitis; Bronchiolitis, Viral

Interventions

Saline Solution, Hypertonic; Epinephrine; Saline Solution

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Virus Diseases

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

• Khalid M. Al-Ansari, FRCPC,FAAP

  Hamad Medical Corporation, Weill Cornell Medical College

  PRINCIPAL INVESTIGATOR

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: INDUSTRY

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 19, 2009
• Study Start: April 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2009
• Last Updated: November 19, 2009

Record last verified: 2009-11

Locations

QA (1)