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

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ClinicalTrials.gov Identifier: NCT03614273
Recruitment Status : Completed
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Jerin C Sekhar, Maulana Azad Medical College

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Bronchiolitis Drug: Hypertonic saline Drug: Adrenaline Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Nebulized Hypertonic Saline (3%) Versus Nebulized Adrenaline for Treatment of Bronchiolitis: A Randomized Control Trial
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : February 29, 2016
Actual Study Completion Date : February 29, 2016


Arm Intervention/treatment
Active Comparator: Group 1 (HS)
Nebulized with 4 ml of 3% hypertonic saline for a duration of 20 minutes
Drug: Hypertonic saline
The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.

Active Comparator: Group 2 (Adr)
Nebulized with 0.1 mg/kg of adrenaline (non-racemic solution, 1:1000 concentration), which was diluted in normal saline to make it a 4 ml solution, for a duration of 20 minutes
Drug: Adrenaline
The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.
Other Name: Epinephrine




Primary Outcome Measures :
  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 Outcome Measures :
  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:

    1. The child had severe audible wheeze with severe respiratory distress (severity score ≥9)
    2. 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.



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Ages Eligible for Study:   1 Month to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614273


Locations
India
Maulana Azad Medical College
New Delhi, Delhi, India, 110002
Sponsors and Collaborators
Maulana Azad Medical College
Investigators
Principal Investigator: Jerin C Sekhar, MD Maulana Azad Medical College

Responsible Party: Jerin C Sekhar, Senior Resident, Department of Pediatrics, Maulana Azad Medical College
ClinicalTrials.gov Identifier: NCT03614273     History of Changes
Other Study ID Numbers: bronchiolitisjer90
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jerin C Sekhar, Maulana Azad Medical College:
nebulization
adrenaline
hypertonic saline
bronchiolitis

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents