Blood PressureNCT01196806
Comparison of Measurement of Arterial Blood Pressure by L&T NIBP Module With Invasive Arterial Blood Pressure in Neonates
An observational study of Blood Pressure, run by Larsen & Toubro Limited.
Trial summary
The purpose of this study is to compare Measurements of Arterial Blood Pressure by L\&T NIBP Module With Invasive Arterial Blood Pressure in Neonates. Read more about this study
- Who is it for?
- Ages 1 minute to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 1 minute to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Total 20 numbers Neonates in NICU were studied during this study.
Who may be able to join
- Neonates admitted to NICU in whom arterial catheterization (radial or umbilical) was clinically indicated for a purpose other than for the comparative study.
Who cannot join
- All neonates in whom arterial catheterization was not clinically indicated.
- If minimum of 5-paired measurements is not obtained either due to technical or clinical reason.
About this study
The purpose of this study is to compare Measurements of Arterial Blood Pressure by L\&T NIBP Module With Invasive Arterial Blood Pressure in Neonates.
- Conditions
- Blood Pressure
- Keywords
- Non-Invasive Blood Pressure(NIBP)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
Sponsor and investigators
- Lead sponsor
- Larsen & Toubro Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196806
- Sponsor's protocol ID
- LTMED02-0910
- Status last verified
- Sep 2010
- First submitted
- 6 Sep 2010
- Last updated
- 8 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Measurement of Arterial Blood Pressure by L&T NIBP Module With Invasive Arterial Blood Pressure in Neonates
- ClinicalTrials.gov ID
- NCT01196806
- Acronym / sponsor ID
- LTMED02-0910
- Conditions
- Blood Pressure
- Keywords
- Non-Invasive Blood Pressure(NIBP)
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Larsen & Toubro LimitedIndustry (pharma, biotech, devices)
- First posted
- 8 Sep 2010 (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.
The purpose of this study is to compare Measurements of Arterial Blood Pressure by L\&T NIBP Module With Invasive Arterial Blood Pressure in Neonates.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 minute to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Total 20 numbers Neonates in NICU were studied during this study.
Key inclusion criteria (1 listed)
- Neonates admitted to NICU in whom arterial catheterization (radial or umbilical) was clinically indicated for a purpose other than for the comparative study.
Key exclusion criteria (2 listed)
- All neonates in whom arterial catheterization was not clinically indicated.
- If minimum of 5-paired measurements is not obtained either due to technical or clinical reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2010.
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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?
An observational study of Blood Pressure, run by Larsen & Toubro Limited.
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 2 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: finished, as of the sponsor's last update on 8 Sep 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 8 Sep 2010.