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Completed

NCT Number: NCT03143231

Normal Saline vs Hypertonic Saline in the Treatment of Bronchiolitis

Background: Bronchiolitis is one of the most common and costly respiratory diseases in infants and young children. Despite the high prevalence and morbidity of bronchiolitis, therapy remains controversial. Supportive care ensuring adequate hydration and oxygenation remains the cornerstone of therapy for these infants.

Over the past 2 decades, research on bronchiolitis management has explored the use of nebulized hypertonic saline that rehydrate the airway surface liquid and improve mucociliary clearance, as well as reduce airway edema.

Aim:The aim of this study is to investigate whether the addition of frequently nebulized hypertonic saline to standard therapy affects the length of stay (LOS) of moderately ill infants hospitalized with bronchiolitis.

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Key information

Conditions

Length of Hospital Stay

Age range

15 day–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Makassed General Hospital

Beirut, Lebanon

About this study

The investigators will conduct this prospective double blind randomized clinical trial by comparing between 2 groups of patients with bronchiolitis, first group will receive 3% hypertonic saline and second group will receive 0.9% saline.

Data collection includes:

Name, Age, Mode of delivery, Birth weight, Current weight, Number of sibling, Immunization record, Duration of breast feeding, past medical history including number of wheezy chest, pneumonia, Parents level of education, Presence of Asthma / Allergic rhinitis in family, Pets /Smoke at home)

Using the validated Respiratory Distress Assessment Instrument (RDAI) investigators will assign patients a score before and at the end of treatment.

To prepare 3% sodium chloride, the investigators will dilute 60 ml 20% sodium chloride injection with 500 ml normal saline (NSS) 0.9%.

Length of stay will be measured in both groups, to establish the efficacy of hypertonic saline in reducing length of stay.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants up to 24 months of age with diagnosis of acute bronchiolitis
  • In accordance with 2006 American Academy of Pediatrics (AAP) definition of bronchiolitis,we did not limit to the first episode of wheeze
  • Patients with the diagnosis of bronchiolitis

Exclusion criteria

  • Chronic lung or heart disease (hemodynamically significant cardiac disease, chronic lung disease / bronchopulmonary dysplasia requiring diuretics or oxygen)
  • Cystic fibrosis, trisomy 21, immunodeficiency / transplant recipient, neuromuscular disease

Treatment and study plan

Normal Saline

Other

The normal saline will be divided in 3ml aliquots that will be preserved in the pharmacy refrigerator between 2 and 60[0]C. Once a patient had been randomized, 6 aliquots would be prepared daily until the end of the trial.

hypertonic saline

Other

The mixture (500 ml Sodium Chloride 0.9% with 60 ml Sodium chloride 20%) will be divided in 3ml aliquots that will be preserved in the pharmacy refrigerator between 2 and 60[0]C. Once a patient had been randomized, 6 aliquots would be prepared daily until the end of the trial.

Primary outcomes

  1. Length of stay

    Time frame: an average of 5 days

    from date of admission to discharge date

Secondary outcomes

  1. transfer to pediatric intensive care unit (PICU)

    Time frame: an average of 3 days

    admission to PICU

  2. use of mechanical ventilator

    Time frame: an average of 3 days

    clinical worsening of patients requiring mechanical ventilator

Sponsors and collaborators

Lead sponsor

Makassed General Hospital

Other

Registry information

Official study title

Normal Saline Versus Hypertonic Saline in the Treatment of Bronchiolitis

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 8, 2017
Registry last updated
Jun 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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