1. VLBW InfantsNCT00266422
Neurological Outcome of VLBW Infants With Early Hypotension
An observational study of 1. VLBW Infants and 2. Hypotension, run by Sheba Medical Center.
Trial summary
Comparison of short and long term neurological outcome of VLBW infants with and without early onset hypotension required intervention. The cohort includes all VLBW infants born in our institution between January 1997 and December 2000. Read more about this study
- Who is it for?
- Ages 0 years to 12 months
- Conditions the study is for
- 1. VLBW Infants, 2. Hypotension
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Dec 2005
- 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 0 years to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -VLBW infants born at the Sheba Medical Center between January 1997 and December 2000
Who cannot join
- none
About this study
Comparison of short and long term neurological outcome of VLBW infants with and without early onset hypotension required intervention. The cohort includes all VLBW infants born in our institution between January 1997 and December 2000.
- Conditions
- 1. VLBW Infants, 2. Hypotension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2005 (estimated)
- Study startJan 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 1. VLBW InfantsStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Jacob Kuint, MD, Study director, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266422
- Sponsor's protocol ID
- SHEBA-05-3950-JK-CTIL
- Status last verified
- Jan 2006
- First submitted
- 15 Dec 2005
- Last updated
- 31 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Outcome of VLBW Infants With Early Hypotension
- ClinicalTrials.gov ID
- NCT00266422
- Acronym / sponsor ID
- SHEBA-05-3950-JK-CTIL
- Conditions
- 1. VLBW Infants, 2. Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2005
- Study completion
- Dec 2005
- First posted
- 16 Dec 2005 (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.
Comparison of short and long term neurological outcome of VLBW infants with and without early onset hypotension required intervention. The cohort includes all VLBW infants born in our institution between January 1997 and December 2000.
Study design
Who may qualify
- Ages
- 0 years to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -VLBW infants born at the Sheba Medical Center between January 1997 and December 2000
Key exclusion criteria (1 listed)
- none
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 31 Jan 2006.
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.
Jacob Kuint, MD study director
Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of 1. VLBW Infants and 2. Hypotension, run by Sheba Medical Center.
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: finished, as of the sponsor's last update on 31 Jan 2006. 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 31 Jan 2006.