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NCT Number: NCT06558461

Nebulised 3% Hypertonic Saline in Infants With Acute Bronchiolitis

This study aims to determine the efficacy of nebulising 3% hypertonic saline in improving clinical symptoms and reducing the length of hospital stay in infants with acute bronchiolitis.

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Key information

Conditions

Acute Bronchiolitis Bronchial Diseases Bronchiolitis Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Can Tho Children's Hospital

Can Tho, 900000, Vietnam

About this study

Bronchiolitis is the most prevalent disease in infants, especially children younger than two years old. Clinical manifestations vary from mild to severe, even life-threatening respiratory failure. Airway oedema and mucus plugging are the principal pathological features in infants with acute bronchiolitis. Nebulising 3% hypertonic saline solution may reduce these pathological changes, but the evidence remains equivocal.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pediatric patients diagnosed with acute bronchiolitis from 1 to 24 months old at Can Tho Children's Hospital.

Exclusion criteria

  • Family members do not agree to let the child participate in the study.
  • Severe respiratory failure required mechanical ventilation.
  • The patient left on his own during treatment.

Treatment and study plan

3% sodium chloride

Drug

4ml nebulized three times daily

Standard care

Other

Standard care

Primary outcomes

  1. Improve clinical severity score after three days of treatment with nebulized 3% hypertonic saline.

    Time frame: three days

    The clinical severity score is a validated, self-reported instrument assessing clinical severity over treatment. Possible scores range from 0 (mild) to 12 (severity).

Secondary outcomes

  1. Shorten the mean length of hospital stays in infants with bronchiolitis after treatment with nebulized 3% hypertonic saline.

    Time frame: From admission to discharge, up to 14 days

    The mean length of hospital stays is the days from admission to discharge of all participants.

Sponsors and collaborators

Lead sponsor

Can Tho University of Medicine and Pharmacy

Other

Registry information

Official study title

Evaluating the Efficacy of Nebulised 3% Hypertonic Saline for Acute Bronchiolitis in Infants: A Study at Can Tho Children's Hospital, 2022-2024

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

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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