PrematureNCT03061968
Study of Applying Acupressure in Low-birth Weight Premature
A study testing acupressure in people with Premature, run by Li-Li Chen.
Trial summary
The purpose of this study is to investigate the effects of acupressure application in very low birth weight premature. Read more about this study
- Who is it for?
- Ages Up to 37 weeks
- Conditions the study is for
- Premature
- What is being tested?
- acupressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Feb 2017
- 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 Up to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- according to the criteria of very low birth weight (<1500gm) from a sick baby room in a medical center.
Who cannot join
- Exclusion criteria of very low birth weight (>1500gm) from a sick baby room in a medical center.
About this study
Official title: Study of Appling Acupressure in Low-birth Weight Premature
The purpose of this study is to investigate the effects of acupressure application in very low birth weight premature.
Read the detailed description
A quasi-experimental study is designed. Sixty premature babies will be recruited by purposed sampling, according to the criteria of very low birth weight (<1500gm) from a sick baby room in a medical center. The control group only receive routine care in sick baby room unite. The babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for 15 days, and continuously recoding the observation and records until discharge. The intervention includes acupressure for 15 minutes each at 10Am, 1Pm and 4Pm.
- Conditions
- Premature
- Being tested
- acupressure
- Keywords
- acupressure, very-low- birth-weight premature, body weight, behavioral state, developmental status
- Medical subject headings
- Premature Birth, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressureBehavioural
The babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for fifteen days, and continuously recoding the observation and records until discharge.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for fifteen days, and continuously recoding the observation and records until discharge. Receives: Behavioral: acupressure |
| control group | No intervention | The control group only receive routine care in sick baby room unite. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
The data will be collected by a self-developed structured questionnaire, including: 1) demographic data of premature; 2)body weight every day until discharge.
Measured: 15 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startMay 2010
- Primary completionDec 2011
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li-Li Chen
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical University Hospital
- Responsible party
- Sponsor-investigator, Li-Li Chen, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061968
- Sponsor's protocol ID
- DMR98-IRB-245-1
- Status last verified
- Feb 2017
- First submitted
- 12 Jan 2011
- Last updated
- 24 Feb 2017
- 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 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Appling Acupressure in Low-birth Weight Premature
- ClinicalTrials.gov ID
- NCT03061968
- Acronym / sponsor ID
- DMR98-IRB-245-1
- Conditions
- Premature
- Keywords
- acupressure, very-low- birth-weight premature, body weight, behavioral state, developmental status
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Li-Li ChenUniversity, hospital or other
- Collaborators
- China Medical University Hospital
- Study start
- May 2010 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2017 (estimated)
- First posted
- 23 Feb 2017 (actual)
- 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.
The purpose of this study is to investigate the effects of acupressure application in very low birth weight premature.
Detailed description
A quasi-experimental study is designed. Sixty premature babies will be recruited by purposed sampling, according to the criteria of very low birth weight (<1500gm) from a sick baby room in a medical center. The control group only receive routine care in sick baby room unite. The babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for 15 days, and continuously recoding the observation and records until discharge. The intervention includes acupressure for 15 minutes each at 10Am, 1Pm and 4Pm.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: acupressureThe babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for fifteen days, and continuously recoding the observation and records until discharge. |
| control group | No intervention | –The control group only receive routine care in sick baby room unite. |
Who may qualify
- Ages
- Up to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- according to the criteria of very low birth weight (<1500gm) from a sick baby room in a medical center.
Key exclusion criteria (1 listed)
- Exclusion criteria of very low birth weight (>1500gm) from a sick baby room in a medical center.
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 |
|---|---|---|
| acupressureThe babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for fifteen days, and continuously recoding the observation and records until discharge. | Behavioural | experimental group |
Primary outcome
Body Weight
Time frame: 15 days.
The data will be collected by a self-developed structured questionnaire, including: 1) demographic data of premature; 2)body weight every day until discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing acupressure in people with Premature, run by Li-Li Chen.
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 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: 15 days.). 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 24 Feb 2017.