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Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children

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ClinicalTrials.gov Identifier: NCT02640066
Recruitment Status : Unknown
Verified June 2016 by Ziv Hospital.
Recruitment status was:  Recruiting
First Posted : December 28, 2015
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):
Ziv Hospital

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.

Condition or disease Intervention/treatment Phase
Viral Respiratory Tract Infection Other: acupuncture Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children: A Single Blinded Randomized Controlled Trial
Study Start Date : June 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: acupuncture
acupuncture treatment with Supportive care
Other: acupuncture
No Intervention: standard treatment
Supportive care measures only



Primary Outcome Measures :
  1. presence of fever [ Time Frame: 5 days ]
  2. presence of cough [ Time Frame: 5 days ]
  3. presence of rhinitis [ Time Frame: 5 days ]
  4. symptoms of pharyngitis [ Time Frame: 5 days ]
  5. presence of crepitations [ Time Frame: 5 days ]
  6. presence of dyspnea or tachypnea [ Time Frame: 5 days ]
    respiratory rate

  7. oxygen saturation [ Time Frame: 5 days ]
    measured by (SpO2)



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Ages Eligible for Study:   3 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02640066


Locations
Israel
Ziv Medical Center Recruiting
Zefat, Israel
Contact: PETER Gilbey, MD       peter.g@ziv.health.gov.il   
Sub-Investigator: YANIV AVRAHAM         
Sponsors and Collaborators
Ziv Hospital

Responsible Party: Ziv Hospital
ClinicalTrials.gov Identifier: NCT02640066     History of Changes
Other Study ID Numbers: 117-15-ZIV
First Posted: December 28, 2015    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases