Effectiveness of Nebulized Hypertonic Saline and Epinephrine in Hospitalized Infants With Bronchiolitis

NCT ID: NCT01300325

Last Updated: 2011-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-12-31

Brief Summary

Acute bronchiolitis is the main cause for respiratory illness that requires hospitalization in children younger than 2 years. In the United States it has been shown that the burden of the disease is considerable, having an annual cost of more than $ 500 million and being responsible for the 17% of all infant hospitalizations . Aim of the present study was to verify the effects of nebulized 3% saline solution in comparison to normal saline in addiction to epinephrine in a large population of RSV positive cases of bronchiolitis; all patients presented a disease as much as severe to require hospitalization.The main study endpoints were the length of stay in hospital and the clinical response.

Detailed Description

Among 136 patients assessed within 12 hours for entry into the study, 109 (69 males) accepted to participate, gave an informed consent and were randomly assigned either to receive every 6 hours the nebulized 0.9% saline (NS) (group I) or the 3% HS (group II) in addition to aerosolized epinephrine (1.5 mg) and to the conventional treatment (oxygen, fluids). Patients were randomized to receive different saline treatments using a computer-based randomization program. Study solutions, prepared by the local hospital pharmacy, were blinded to participants and investigators. Each treatment was delivered by a nebulizer with continuous flow of oxygen at 6 L/min through a tight-fitting facemask.

The main study endpoints were the length of stay (LOS) in hospital and the clinical response. LOS in hospital was defined as the time between study entry (within 12 hours of admission to the hospital) and the time at which the infant was discharged on the basis of the clinical grounds by the attending physician. Clinical response was determined using daily CSS evaluation; furthermore, the CSS was evaluated every day before and 30 minutes after nebulisation.

Conditions

Bronchiolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

0.9% saline

patients receive every 6 hours the nebulized 0.9% saline (placebo comparator) (group I) or the 3% HS (group II) in addition to aerosolized epinephrine (1.5 mg) and to the conventional treatment (oxygen, fluids).

Group Type: PLACEBO_COMPARATOR

3% hypertonic saline solution

Intervention Type: OTHER

Patients receive every 6 hours the nebulized 0.9% saline (Placebo comparator) (group I) or the 3% hypertonic saline solution group II) in addition to aerosolized epinephrine (1.5 mg) and to the conventional treatment (oxygen, fluids).

3% hypertonic saline

Patients receive every 6 hours the nebulized 0.9% saline (Placebo comparator) (group I) or the 3% hypertonic saline solution group II) in addition to aerosolized epinephrine (1.5 mg) and to the conventional treatment (oxygen, fluids).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

3% hypertonic saline solution

Patients receive every 6 hours the nebulized 0.9% saline (Placebo comparator) (group I) or the 3% hypertonic saline solution group II) in addition to aerosolized epinephrine (1.5 mg) and to the conventional treatment (oxygen, fluids).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• children aged less than 2 years old
• clinical diagnosis of bronchiolitis

Exclusion Criteria

• cardiac or pulmonary diseases
• premature birth < 36 weeks of gestational age
• previous diagnosis of asthma
• an initial oxygen saturation of 85%

• Minimum Eligible Age: 30 Days
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Dipartimento di Pediatria

Principal Investigators

Michele Miraglia, MD

Role: STUDY_DIRECTOR

Pediatric Department

Locations

Azienda Sanitaria Locale Napoli 2 Nord

Pozzuoli, Napoli, Italy

Countries

Italy

Other Identifiers

ENHS

Identifier Type: -

Identifier Source: org_study_id