Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00153855
Status:
TERMINATED
Last Update Posted:
2006-09-08
First Post:
2005-09-08
Brief Title:
Structural Brain Abnormalities in Children Born Prematurely New Detection Methods and Clinical-Pathological Correlates
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Structural Brain Abnormalities in Children Born Prematurely New Detection Methods and Clinical-Pathological Correlates
Status:
TERMINATED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to detect structural brain changes using MRI and to correlate these findings with neurodevelopmental assessments in two-year old children previously enrolled in the NIH sponsored trial of inhaled Nitric Oxide iNO for the prevention of Chronic Lung Disease in preterm ventilated infants It is hypothesized that this imaging will identify children with previously undiagnosed brain abnormalities and that the presence of structural abnormalities will be associated with deficits in motor cognitive and neurosensory development
Detailed Description:
Infants born prematurely are at significant risk for hemorrhagic and ischemic brain injury Despite improved survival rates among this population in recent years these forms of brain injury remain frequent and have considerable consequences Periventricular leukomalacia PVL a disease characterized by necrosis of the cerebral white matter in a characteristic distribution is one of the most common types of brain injury seen in premature infants MRI technology now allows for better anatomical resolution resulting in improvements in diagnostic accuracy The current standard practice is not to perform routine MRI examinations on premature infants nor is it routine to perform surveillance brain imaging in children after leaving the NICU In their 2002 Practice Parameter for neuroimaging in the neonate the American Academy of Neurology and the Practice Committee of the Child Neurology Society acknowledge the superiority of MRI in detection of brain lesions in premature infants but fall short of recommending routine MRI scanning on the basis of a lack of information correlating MRI findings to neurodevelopmental outcomes We now have a unique opportunity to help provide such information
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None