Child DevelopmentNCT00194831
Correlation of Volumetric Brain Analysis With Development at 18 Months
An observational study of Child Development, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The study will correlate the volumes of the brain obtained from magnetic resonance imaging (MRI) scans done at term gestation for infants born prematurely who weighed less than 1000 grams at birth with their corresponding development at 18 months corrected age. Read more about this study
- Who is it for?
- Ages 18 months to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jun 2015
- 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 18 months to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Premature infants < 1000 gram birthweight who are followed post discharge as part of standard clinical care
Who may be able to join
- All premature infants born < 1000 grams who had MRI scans of the brain at term gestation
Who cannot join
- Any known genetic or chromosomal abnormalities
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital Weill Cornell
New York, New York, 10021
About this study
Official title: Volumetric Brain Analysis in the Premature Brain: Correlation With Future Development
The study will correlate the volumes of the brain obtained from magnetic resonance imaging (MRI) scans done at term gestation for infants born prematurely who weighed less than 1000 grams at birth with their corresponding development at 18 months corrected age.
- Conditions
- Child Development
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: No data. Study never completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Observational model
- Cohort
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Investigators
- Jeffrey M Perlman, MB, Study chair, New York Presbyterian Hospital Weill Cornell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194831
- Sponsor's protocol ID
- 000501007693
- Status last verified
- Jun 2015
- First submitted
- 12 Sep 2005
- Last updated
- 15 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric Brain Analysis in the Premature Brain: Correlation With Future Development
- ClinicalTrials.gov ID
- NCT00194831
- Acronym / sponsor ID
- 000501007693
- Conditions
- Child Development
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No data. Study never completed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Sep 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.
The study will correlate the volumes of the brain obtained from magnetic resonance imaging (MRI) scans done at term gestation for infants born prematurely who weighed less than 1000 grams at birth with their corresponding development at 18 months corrected age.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 months to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Premature infants < 1000 gram birthweight who are followed post discharge as part of standard clinical care
Key inclusion criteria (1 listed)
- All premature infants born < 1000 grams who had MRI scans of the brain at term gestation
Key exclusion criteria (1 listed)
- Any known genetic or chromosomal abnormalities
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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
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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.
Jeffrey M Perlman, MB study chair
New York Presbyterian Hospital Weill Cornell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development, run by Weill Medical College of Cornell University at 1 site in United States.
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: withdrawn, as of the sponsor's last update on 15 Jun 2015. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 15 Jun 2015.