Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2015
CompletedFirst Posted
Study publicly available on registry
December 28, 2015
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedJune 9, 2016
June 1, 2016
1.7 years
December 22, 2015
June 8, 2016
Conditions
Outcome Measures
Primary Outcomes (7)
presence of fever
5 days
presence of cough
5 days
presence of rhinitis
5 days
symptoms of pharyngitis
5 days
presence of crepitations
5 days
presence of dyspnea or tachypnea
respiratory rate
5 days
oxygen saturation
measured by (SpO2)
5 days
Study Arms (2)
acupuncture
EXPERIMENTALacupuncture treatment with Supportive care
standard treatment
NO INTERVENTIONSupportive care measures only
Interventions
Eligibility Criteria
You may qualify if:
- The presence of acute viral respiratory disease
You may not qualify if:
- Evidence of chronic cardio-pulmonary disease, immune-suppression or any chronic systemic disease or disability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ziv Hospitallead
Study Sites (1)
Ziv Medical Center
Safed, Israel
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2015
First Posted
December 28, 2015
Study Start
June 1, 2016
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
June 9, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share