Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children

• Sponsor: Ziv Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02640066
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 3

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Jun 1, 2016
• Anticipated Primary Completion Date: Feb 1, 2018
• Anticipated Study Completion Date: Feb 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. presence of fever [5 days]

2. presence of cough [5 days]

3. presence of rhinitis [5 days]

4. symptoms of pharyngitis [5 days]

5. presence of crepitations [5 days]

6. presence of dyspnea or tachypnea [5 days]

   respiratory rate

7. oxygen saturation [5 days]

   measured by (SpO2)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months to 36 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ziv Medical Center	Zefat		Israel

Sponsors and Collaborators

• Ziv Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ziv Hospital
• ClinicalTrials.gov Identifier: NCT02640066
• Other Study ID Numbers: 117-15-ZIV
• First Posted: Dec 28, 2015
• Last Update Posted: Jun 9, 2016
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections

Study Results

No Results Posted as of Jun 9, 2016