Viral Respiratory Tract InfectionNCT02640066
Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children
A study testing acupuncture in people with Viral Respiratory Tract Infection, run by Ziv Hospital at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 3 to 36 months
- Conditions the study is for
- Viral Respiratory Tract Infection
- What is being tested?
- acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The presence of acute viral respiratory disease
Who cannot join
- Evidence of chronic cardio-pulmonary disease, immune-suppression or any chronic systemic disease or disability
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Ziv Medical Center
Safed
PETER Gilbey, MD, peter.g@ziv.health.gov.il
YANIV AVRAHAM
About this study
Official title: 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.
- Conditions
- Viral Respiratory Tract Infection
- Being tested
- acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
| Study group | Role | What they receive |
|---|---|---|
| acupuncture | Experimental | acupuncture treatment with Supportive care Receives: Other: acupuncture |
| standard treatment | No intervention | Supportive care measures only |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of fever
Measured: 5 days
presence of cough
Measured: 5 days
presence of rhinitis
Measured: 5 days
symptoms of pharyngitis
Measured: 5 days
presence of crepitations
Measured: 5 days
presence of dyspnea or tachypnea
respiratory rate
Measured: 5 days
oxygen saturation
measured by (SpO2)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2015 (estimated)
- Study startJun 2016
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640066
- Sponsor's protocol ID
- 117-15-ZIV
- Status last verified
- Jun 2016
- First submitted
- 22 Dec 2015
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children: A Single Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02640066
- Acronym / sponsor ID
- 117-15-ZIV
- Conditions
- Viral Respiratory Tract Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Jun 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 28 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Experimental | Other: acupunctureacupuncture treatment with Supportive care |
| standard treatment | No intervention | –Supportive care measures only |
Who may qualify
- Ages
- 3 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The presence of acute viral respiratory disease
Key exclusion criteria (1 listed)
- Evidence of chronic cardio-pulmonary disease, immune-suppression or any chronic systemic disease or disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncture | Other | acupuncture |
Primary outcome
presence of fever
Time frame: 5 days
presence of cough
Time frame: 5 days
presence of rhinitis
Time frame: 5 days
symptoms of pharyngitis
Time frame: 5 days
presence of crepitations
Time frame: 5 days
presence of dyspnea or tachypnea
Time frame: 5 days
respiratory rate
oxygen saturation
Time frame: 5 days
measured by (SpO2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Viral Respiratory Tract Infection, run by Ziv Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of fever (time frame: 5 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.