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Trial record 2 of 35 for:    "Bronchial Disease" | "Epinephrine"

Nebulized Epinephrine vs. Salbutamol in Bronchiolitis Among Children

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ClinicalTrials.gov Identifier: NCT03814954
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Mariam Rajab, Makassed General Hospital

Brief Summary:
Acute bronchiolitis, mostly secondary to infection due to Respiratory syncytial virus (RSV) is very common in infants under two years old. It is usually benign. However, the dyspnea it causes is a big concern for parents and this disease can take a severe form on certain particular ground thus constituting a frequent reason for hospitalization in pediatrics. Nebulized epinephrine showed more efficacy than nebulized salbutamol.

Condition or disease Intervention/treatment Phase
Respiratory Distress Score Drug: Salbutamol Drug: Epinephrine Not Applicable

Detailed Description:

The objective of this study is to determine if nebulized epinephrine is more efficacious than nebulized salbutamol in all hospitalized children (1 month to 24 months) in treatment of bronchiolitis. A randomized clinical trial which recruits children admitted to the pediatrics department with diagnosis of bronchiolitis. Children aged 1 month to 2 years will be included in the study.

Children who meet the inclusion criteria will be alternately distributed in two groups:

Group 1:

Will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer.

Group 2:

Will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer. All admitted patients will receive aerosol every 20 minutes three times and after, depending on the clinical status of the patients, they will be given oxygen therapy at 1.5 liters / minute at the admission if oxygen saturation is below 94% till the normalization of the oxygen saturation.

Clinical parameters such as clinical score, oxygen saturation with pulse oximetry, heart rate, and temperature will be measured at admission, at hour 1 to hour 12 and then every 24 hours until they are discharged.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nebulized Epinephrine Versus Nebulized Salbutamol in Bronchiolitis Among Children Aged 1month-24months
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : February 15, 2020


Arm Intervention/treatment
Active Comparator: Salbutamol
Patients will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer.
Drug: Salbutamol
At first day of admission, patients will receive 3 doses of nebulized salbutamol every 20 minutes. Then after 24 hours patients will receive standing dose according to clinical status

Experimental: Epinephrine
Patients will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer.
Drug: Epinephrine
At first day of admission, patients will receive 3 doses of nebulized epinephrine every 20 minutes. Then after 24 hours patients will receive standing dose according to clinical status




Primary Outcome Measures :
  1. Length of stay [ Time Frame: 5 days ]
    Patients hospitalization duration will be recorded


Secondary Outcome Measures :
  1. Respiratory distress scoring [ Time Frame: 5 days ]
    The score will be measured through Silverman-Andersen Retraction scoring. The minimum score is 0 indicating no distress. The maximum score is 10 indicating severe respiratory distress



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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children diagnosed with acute bronchiolitis.

Exclusion Criteria:

  • Children with congenital heart disease or
  • chronic lung diseases

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): NCT03814954


Contacts
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Contact: Mariam A Rajab, MD +9611636000 ext 6317 drmariam1@hotmail.com

Locations
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Lebanon
Makassed General Hospital Recruiting
Beirut, Lebanon
Contact: Mariam Rajab, MD    +9611636000 ext 6317    drmariam1@hotmail.com   
Sponsors and Collaborators
Makassed General Hospital
Investigators
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Principal Investigator: Mariam Rajab, MD Makassed General Hospital

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Responsible Party: Mariam Rajab, Clinical professor, Makassed General Hospital
ClinicalTrials.gov Identifier: NCT03814954     History of Changes
Other Study ID Numbers: 1812182
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019

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

Additional relevant MeSH terms:
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Bronchial Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Bronchiolitis
Bronchitis
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Albuterol
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
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists