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Completed

NCT Number: NCT06069336

Nebulised 3% Hypertonic Saline Versus 0.9% Saline for Treating Patients Hospitalized With Acute Bronchiolitis

Bronchiolitis is an acute viral infection of the lower respiratory tract. It is most commonly caused by respiratory syncytial virus (RSV). Only supportive therapy, including suctioning nasal secretions, water-electrolyte balance maintenance, and oxygen supplementation when needed, is recommended. The inhalation of 3% hypertonic saline is not recommended in bronchiolitis management. However, a recently published meta-analysis revealed that the inhalation of hypertonic saline can reduce the risk of hospitalisation for outpatients with bronchiolitis, while resulting in a shorter length of hospital stay and reduced severity of respiratory distress for inpatients, although the evidence is of low certainty.

The aim of the study is to assess the efficacy of nebulised hypertonic saline for the treatment of children hospitalised with bronchiolitis.

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Key information

Age range

5 week–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Szpiatal im.Świętej Jadwigi Śląskiej, Trzebnica, Poland

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children admitted to the hospital with the clinical diagnosis of acute bronchiolitis, which is defined as an apparent viral respiratory tract infection associated with airway obstruction manifested by at least one of following symptoms:
  • Tachypnoea (WHO definition).
  • Increased respiratory effort manifested as follows:
  • Nasal flaring;
  • Grunting;
  • Use of accessory muscles;
  • Intercostal and/or subcostal chest wall retractions;
  • Apnoe.
  • Crackles and/or wheezing.
  • Aged 5 weeks - 24 months old.
  • A caregiver must provide written informed consent.

Exclusion criteria

  • Infants hospitalised with severe bronchiolitis (requiring mechanical ventilation or intensive care, or oxygen saturation < 85% on room air).
  • History of prematurity (gestational age <34 weeks).
  • Diagnosis of a clinically significant chronic disease (cardiac, respiratory, neuromuscular, or metabolic).
  • Immunodeficiency.
  • Gastro-oesophageal reflux.
  • Diagnosis or suspicion of asthma.
  • Inhaling a nebulised 3% hypertonic saline solution within 12 hours before enrolment.
  • Inhaling bronchodilators within 24 hours before enrolment.
  • Inhaling steroids within 24 hours before enrolment.
  • Systemic steroid therapy in the preceding 2 weeks.

Treatment and study plan

Hypertonic saline

Drug

Nebulised 3% hypertonic saline (NEBU-dose hypertonic). Nebulisation will be performed by trained study nurses or by parents under the supervision of a nurse

normal saline

Drug

0,9% normal saline (NEBU-dose isotonic). Nebulisation will be performed by trained study nurses or by parents under the supervision of a nurse

Primary outcomes

  1. Length of hospital stay (LOS).

    Time frame: From admission to hospital discharge

Secondary outcomes

  1. Number of participants requiring oxygen supplementation

    Time frame: During the intervention

  2. Duration of oxygen supplementation

    Time frame: During the intervention

    among those requiring oxygen

  3. The time until the infant will be assessed as being 'fit for discharge'

    Time frame: During the intervention

    which is defined as the point at which the infant will be feeding adequately (taking >75% of their usual intake based on parents' assessment) and will have a saturation of at least 92% for 6 h on room air, while the axillary body temperature will remain - among those requiring oxygen

  4. Number of participants requiring hospital readmission after discharge

    Time frame: 7 days after the end of interventions

  5. Number of adverse events

    Time frame: 7 days after the end of interventions

    especially incidence of acute otitis media and pneumonia

  6. Worsening of clinical status, including the following:

    Time frame: During the intervention

    PICU admission The need for oxygen supplementation via HNFC; Bronchospasm within 30 minutes of a nebulised study treatment as indicated by an increase/worsening of the RDAI of <4 points.

  7. Value of clinical severity score (RDAI and Wang Scale)

    Time frame: During the intervention

    30 minutes after intervention and 24 h, 48 h, and 72 h after enrolment

Sponsors and collaborators

Lead sponsor

Szpital im. Św. Jadwigi Śląskiej

Other

Registry information

Official study title

Nebulised 3% Hypertonic Saline Versus 0.9% Saline for Treating Patients Hospitalized With Acute Bronchiolitis: Protocol of a Randomized, Double-blind, Multicentre Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 5, 2023
Registry last updated
May 18, 2025

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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