Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-30 @ 6:33 PM
Study NCT ID:
NCT02640066
Status:
UNKNOWN
Last Update Posted:
2016-06-09
First Post:
2015-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-08', 'studyFirstSubmitDate': '2015-12-22', 'studyFirstSubmitQcDate': '2015-12-24', 'lastUpdatePostDateStruct': {'date': '2016-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'presence of fever', 'timeFrame': '5 days'}, {'measure': 'presence of cough', 'timeFrame': '5 days'}, {'measure': 'presence of rhinitis', 'timeFrame': '5 days'}, {'measure': 'symptoms of pharyngitis', 'timeFrame': '5 days'}, {'measure': 'presence of crepitations', 'timeFrame': '5 days'}, {'measure': 'presence of dyspnea or tachypnea', 'timeFrame': '5 days', 'description': 'respiratory rate'}, {'measure': 'oxygen saturation', 'timeFrame': '5 days', 'description': 'measured by (SpO2)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Viral Respiratory Tract Infection']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The presence of acute viral respiratory disease\n\nExclusion Criteria:\n\n* Evidence of chronic cardio-pulmonary disease, immune-suppression or any chronic systemic disease or disability'}, 'identificationModule': {'nctId': 'NCT02640066', 'briefTitle': 'Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ziv Hospital'}, 'officialTitle': 'Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children: A Single Blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '117-15-ZIV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'acupuncture', 'description': 'acupuncture treatment with Supportive care', 'interventionNames': ['Other: acupuncture']}, {'type': 'NO_INTERVENTION', 'label': 'standard treatment', 'description': 'Supportive care measures only'}], 'interventions': [{'name': 'acupuncture', 'type': 'OTHER', 'armGroupLabels': ['acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Safed', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'PETER Gilbey, MD', 'role': 'CONTACT', 'email': 'peter.g@ziv.health.gov.il'}, {'name': 'YANIV AVRAHAM', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ziv Medical Center', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziv Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}