Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children

NCT ID: NCT02640066

Last Updated: 2016-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-02-28

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.

Conditions

Viral Respiratory Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

acupuncture

acupuncture treatment with Supportive care

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: OTHER

standard treatment

Supportive care measures only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

acupuncture

Intervention Type: OTHER

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziv Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ziv Medical Center

Safed, , Israel

Site Status: RECRUITING

Countries

Israel

Facility Contacts

PETER Gilbey, MD

Role: primary

peter.g@ziv.health.gov.il

Other Identifiers

117-15-ZIV

Identifier Type: -

Identifier Source: org_study_id