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Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children

Primary Purpose

Viral Respiratory Tract Infection

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Ziv Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Viral Respiratory Tract Infection

Eligibility Criteria

3 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The presence of acute viral respiratory disease

Exclusion Criteria:

  • Evidence of chronic cardio-pulmonary disease, immune-suppression or any chronic systemic disease or disability

Sites / Locations

  • Ziv Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

acupuncture

standard treatment

Arm Description

acupuncture treatment with Supportive care

Supportive care measures only

Outcomes

Primary Outcome Measures

presence of fever
presence of cough
presence of rhinitis
symptoms of pharyngitis
presence of crepitations
presence of dyspnea or tachypnea
respiratory rate
oxygen saturation
measured by (SpO2)

Secondary Outcome Measures

Full Information

First Posted
December 22, 2015
Last Updated
June 8, 2016
Sponsor
Ziv Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02640066
Brief Title
Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children
Official Title
Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children: A Single Blinded Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ziv Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Acute viral respiratory infections are among the most common causes of hospitalization in the pediatric population. The usual presentation of viral respiratory tract infections (VRTI) includes fever, malaise, wheezing and or coughing, rhinorrhea and loss of appetite. Up to 50% of children will have at least one viral-induced wheezing illness by school age. Currently treatment of VRTI is essentially supportive and no specific and efficient treatments are known. Given the lack of effective medications, current treatment for severe viral lower respiratory tract infection (LRTI) in infants relies on supportive measures only. These measures include supplementation of oxygen, monitoring of apnea, nasal/gastric tube feeding or intravenous fluids, and, if required, respiratory support with nasal bi-level positive-airway pressure. VTRI therefore represent an important unmet need for improved treatment strategies. Acupuncture's effect on has also been studied. Acupuncture has been shown to be a safe and effective in various respiratory tract inflammations. A review published in 2011 have found that acupuncture is safe for pediatric patients. Acupuncture's effect on acute viral induced wheezing and cough in hospitalized children has yet to be studied. Since the current standard of care is supportive care only, using acupuncture as an additional treatment may provide benefit in reducing wheezing, respiratory distress, and shorten hospitalization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Respiratory Tract Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
acupuncture
Arm Type
Experimental
Arm Description
acupuncture treatment with Supportive care
Arm Title
standard treatment
Arm Type
No Intervention
Arm Description
Supportive care measures only
Intervention Type
Other
Intervention Name(s)
acupuncture
Primary Outcome Measure Information:
Title
presence of fever
Time Frame
5 days
Title
presence of cough
Time Frame
5 days
Title
presence of rhinitis
Time Frame
5 days
Title
symptoms of pharyngitis
Time Frame
5 days
Title
presence of crepitations
Time Frame
5 days
Title
presence of dyspnea or tachypnea
Description
respiratory rate
Time Frame
5 days
Title
oxygen saturation
Description
measured by (SpO2)
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The presence of acute viral respiratory disease Exclusion Criteria: Evidence of chronic cardio-pulmonary disease, immune-suppression or any chronic systemic disease or disability
Facility Information:
Facility Name
Ziv Medical Center
City
Zefat
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PETER Gilbey, MD
Email
peter.g@ziv.health.gov.il
First Name & Middle Initial & Last Name & Degree
YANIV AVRAHAM

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children

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