Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children

Viral Respiratory Tract Infection Clinical Trial

Official title:

Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children: A Single Blinded Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02640066
• Other study ID #: 117-15-ZIV
• Status: Recruiting
• Phase: N/A
• First received: December 22, 2015
• Last updated: June 8, 2016
• Start date: June 2016
• Est. completion date: February 2018

Study information

• Verified date: June 2016
• Source: Ziv Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 36 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Respiratory Tract Infections
• Viral Respiratory Tract Infection

Intervention

Other:
• acupuncture

Locations

Country	Name	City	State
Israel	Ziv Medical Center	Zefat

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of fever		5 days	No
Primary	presence of cough		5 days	No
Primary	presence of rhinitis		5 days	No
Primary	symptoms of pharyngitis		5 days	No
Primary	presence of crepitations		5 days	No
Primary	presence of dyspnea or tachypnea	respiratory rate	5 days	No
Primary	oxygen saturation	measured by (SpO2)	5 days	No