NCT00194831

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 15, 2015

Status Verified

June 1, 2015

Enrollment Period

10 years

First QC Date

September 12, 2005

Last Update Submit

June 11, 2015

Conditions

Child Development

Eligibility Criteria

Age18 Months - 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Premature infants \< 1000 gram birthweight who are followed post discharge as part of standard clinical care

You may qualify if:

  • All premature infants born \< 1000 grams who had MRI scans of the brain at term gestation

You may not qualify if:

  • Any known genetic or chromosomal abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian Hospital Weill Cornell

New York, New York, 10021, United States

Location

Study Officials

  • Jeffrey M Perlman, MB

    New York Presbyterian Hospital Weill Cornell

    STUDY CHAIR
0

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

June 1, 2005

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 15, 2015

Record last verified: 2015-06

Locations

US(1)