Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children

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

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.

Study Overview

• Status: Unknown
• Conditions: Viral Respiratory Tract Infection
• Intervention / Treatment: Other: acupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Zefat, Israel
    • Recruiting
    • Ziv Medical Center
    • Sub-Investigator: YANIV AVRAHAM
    • Contact: PETER Gilbey, MD; Email: peter.g@ziv.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acupuncture; acupuncture treatment with Supportive care	Other: acupuncture
No Intervention: standard treatment; Supportive care measures only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ziv Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: December 22, 2015
• First Submitted That Met QC Criteria: December 24, 2015
• First Posted (Estimate): December 28, 2015

Study Record Updates

• Last Update Posted (Estimate): June 9, 2016
• Last Update Submitted That Met QC Criteria: June 8, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 117-15-ZIV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO