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Completed

NCT Number: NCT03614273

Nebulized Hypertonic Saline (3%) Versus Nebulized Adrenaline for Treatment of Bronchiolitis

The primary objective of this study was to compare the effectiveness of nebulized hypertonic saline (3%) and nebulized adrenaline in bronchiolitis. The secondary objective was to assess whether non-responders to initial therapy benefit from continuation of the same therapy.

This trial was conducted at a tertiary care teaching hospital over a period of one year in children with bronchiolitis presenting to the out-patient department and emergency. After obtaining a signed informed consent from the parents, all eligible children were assessed for baseline characteristics. A complete hemogram, chest X-ray were done in all and arterial blood gas analysis where ever required.

Computer generated random numbers were used for enrolment in consecutive manner and patients were randomly assigned into two groups. The first group received one dose (4ml) of nebulized hypertonic saline (3%).The second group received one dose (0.1 mg/kg) of nebulized adrenaline diluted in normal saline to make it a 4ml solution. Supportive care (nasal clearing, antipyretics, oxygenation, intravenous fluids) was done in both groups as necessary.

All children were reassessed 20 minutes after one dose of nebulization using the clinical score and a child was labelled as a "responder" if he showed an improvement in the clinical severity score by atleast 3 points after 20 minutes of nebulization. Both responders and non-responders were given a repeat dose of nebulization according to the group to which the child had been randomized, if: a) Severe audible wheeze with severe respiratory distress (severity score ≥9) b) Inability to maintain saturation >92% even on an O2 flow of 4 L/min. Non responders were given a maximum of three continuous doses of nebulization.

Child was considered fit for discharge if he/she was feeding well orally, there was no need for intravenous fluids, clinical severity score ≤3 and maintaining oxygen saturation >92% on room air for a period of more than 12 hours.

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Key information

Age range

1 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maulana Azad Medical College

New Delhi, National Capital Territory of Delhi, 110002, India

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children aged 1 month to 2 years with moderate to severe bronchiolitis as per Wang score

Exclusion criteria

  • Comorbidities such as congenital heart disease, bronchopulmonary dysplasia, cystic fibrosis, neurological diseases
  • Known or suspected immunodeficiency
  • Congenital malformations
  • History of use of steroids within one week prior to presentation
  • Severe disease requiring admission to intensive care unit/mechanical ventilation

Treatment and study plan

Hypertonic saline

Drug

The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.

Adrenaline

Drug

The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.

Other names: Epinephrine

Primary outcomes

  1. Duration of hospital stay

    Time frame: During hospitalization, approximately 2 days

    Duration from the time of enrolment to the point at which the discharge criteria (feeding well orally, no need for intravenous fluids, clinical severity score ≤ 3 and maintaining oxygen saturation >92% on room air for a period of more than 12 hours) are met.

Secondary outcomes

  1. Initial change in the Wang bronchiolitis clinical severity score

    Time frame: 20 minutes after the first nebulization

    A decrease in the Wang bronchiolitis clinical severity score by at least 3 points after 20 minutes of nebulization was considered as an improvement in the clinical condition. The Wang score ranges from 0 - 12 [0-4: mild, 5-8: moderate, 9-12: severe].

  2. Number of hours of intravenous fluid requirement

    Time frame: During hospitalization, approximately 2 days

    Intravenous fluids were given to children unable to accept orally.

  3. Number of hours of oxygen requirement

    Time frame: Till the time the child maintained a saturation of more than 94% for at least 4 hours

    Oxygen was administered when the saturation was less than 92%

  4. Number of doses of nebulization needed

    Time frame: During hospitalization, approximately 2 days

    Indications for repeat dose were if:

    • The child had severe audible wheeze with severe respiratory distress (severity score ≥9)
    • The child was not able to maintain saturation >92% even on an oxygen flow of 4 L/min
  5. Response after each nebulization

    Time frame: Assessed 20 minutes after each nebulization

    An improvement in the clinical severity score by at least 3 points after each nebulization.

Sponsors and collaborators

Lead sponsor

Maulana Azad Medical College

Other

Registry information

Official study title

Nebulized Hypertonic Saline (3%) Versus Nebulized Adrenaline for Treatment of Bronchiolitis: A Randomized Control Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 3, 2018
Registry last updated
Aug 3, 2018

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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