Efficacy of Nebulised Hypertonic Saline (3%) Among Children With Bronchiolitis.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Aayush Khanal, MD, Tribhuvan University Teaching Hospital, Institute Of Medicine.
ClinicalTrials.gov Identifier:
NCT01276821
First received: January 12, 2011
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

To assess the efficacy of nebulized 3% hypertonic saline in improving clinical severity scores among children aged 6 weeks to 24 months with bronchiolitis.


Condition Intervention Phase
Bronchiolitis
Drug: L-Epinephrine and Normal Saline (0.9%)
Drug: L-Epinephrine and Hypertonic Saline (3%)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Nebulised Hypertonic Saline (3%) Among Children With Mild to Moderately Severe Bronchiolitis - A Double Blind Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Tribhuvan University Teaching Hospital, Institute Of Medicine.:

Primary Outcome Measures:
  • Mean Change in Clinical Severity Score [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

    Mean changes in the Clinical Severity Score after 2 sessions of nebulisation as compared to baseline.

    Clinical Severity Score devised by Wang et al, is an objective scoring system that measures the degree of respiratory distress in young children.

    The scoring system assesses respiratory rate, wheezing, retraction, and general condition,scores ranging from 0 to 3, with higher scores indicating severe illness and vice versa.

    The total scores range from 0 to 12, with increased severity receiving a higher score (Wang et al, 1992).

    This scoring systems have previously been validated in a number of well designed randomized controlled trials(Anil 2010, Kuzik 2007, Sarrell 2002, and Mandelberg 2003). A 1 point improvement in the clinical severity score implies approximately 7% betterment of symptoms on the scale.



Secondary Outcome Measures:
  • Patients Meeting Eligibility Criteria for ER/ OPD Discharge at the End of 2 Hours of Observation [ Time Frame: At the end of 2 hours ] [ Designated as safety issue: No ]
  • Relapse Rate [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    To study the number of patients in either group who need another unscheduled medical visit within the initial 24 hours of ER/ OPD visit

  • Need for Unscheduled Medical Visits, if Any, for Same Symptoms to Any Healthcare Facility Within 1 Week [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Missed Days of Work of Caregivers [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Number of patients in each intervention group whose parents reported at least 1 day of missed work due to the illness of child within the week following the initial hospital visit on 7 day follow-up call.

  • Persistence of Cough at the End of 1 Week [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Number of patients in each intervention group whose parents reported the persistence of initial cough at the end of 1 week in their children.


Other Outcome Measures:
  • Average Duration of Crying (in Minutes) Among Babies Receiving Nebulisation Therapy. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    The outcomes tries to compare the influence of duration of crying among babies receiving nebulization which interferes with drug delivery and henceforth might create a confounding bias while interpreting results.


Enrollment: 100
Study Start Date: January 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Standard Treatment
L-Epinephrine and Normal Saline (0.9%)
Drug: L-Epinephrine and Normal Saline (0.9%)
1.5ml of 1:1,000 L-Epinephrine and 4 ml of 0.9% Normal Saline
Other Name: Nebulised Epinephrine in 0.9% Normal saline
Active Comparator: Study Treatment
L-Epinephrine and Hypertonic Saline (3%)
Drug: L-Epinephrine and Hypertonic Saline (3%)
1.5ml of 1:1,000 L-Epinephrine and 4 ml of 3% Hypertonic Saline
Other Name: Nebulised Epinephrine in 3% Hypertonic Saline

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Weeks to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 6 weeks to 24 Months.
  • First episode of wheezing
  • Fever, cough and watery nasal discharge

Exclusion Criteria :

  • Any underlying cardiovascular disease.
  • Prior wheezing.
  • Clinical Severity Score > 9.
  • Atopic dermatitis, allergic rhinitis or asthma.
  • Oxygen saturation (SpO2) <85% on room air.
  • Obtunded consciousness.
  • Previous treatment with bronchodilators within 4 hours.
  • Any steroid therapy within 48 Hours.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276821

Locations
Nepal
Out Patient Department and Emergency Department, Kanti Children Hospital
Kathmandu, Bagmati Zone, Nepal, 44600
Sponsors and Collaborators
Dr. Aayush Khanal, MD
Investigators
Principal Investigator: Aayush Khanal, MD Department of Child Health , Institute of Medicine , Tribhuvan University Teaching Hospital.
Study Director: Arun Sharma, MD Department of Child Health , Tribhuvan University Teaching Hospital , Institute of Medicine, Maharajgunj, Kathmandu ,Nepal.
Study Director: Srijana Basnet, MD Department of Child Health , Tribhuvan University Teaching Hospital , Institute of Medicine , Maharajgunj , Kathmandu , Nepal.
Study Chair: Pushpa R Sharma, DCH,FCPS Head of the Department. Department of Child Health , Tribhuvan University Teaching Hospital , Institute of Medicine , Maharajgunj , Kathmandu , Nepal.
Study Chair: Fakir C Gami, MD Department of Child Health, Tribhuvan University Teaching Hospital, Institute of Medicine.
  More Information

No publications provided

Responsible Party: Dr. Aayush Khanal, MD, MD, Tribhuvan University Teaching Hospital, Institute Of Medicine.
ClinicalTrials.gov Identifier: NCT01276821     History of Changes
Other Study ID Numbers: PEDSTUTHIOM
Study First Received: January 12, 2011
Results First Received: September 11, 2012
Last Updated: April 23, 2013
Health Authority: Nepal: Health Research Council

Keywords provided by Tribhuvan University Teaching Hospital, Institute Of Medicine.:
Bronchiolitis
L-Epinephrine
3% Hypertonic Saline
Clinical Severity Score

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
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 20, 2014