Status:
TERMINATED
Structural Brain Abnormalities in Children Born Prematurely: New Detection Methods and Clinical-Pathological Correlates
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Boston Children's Hospital
Children's Mercy Hospital Kansas City
Conditions:
Infant, Premature
Brain Injuries
Eligibility:
All Genders
24-27 years
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 spo...
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 fr...
Eligibility Criteria
Inclusion
- must be participants in trial (NHLBI-UO1-HL62514-05A1 and FDA IND # 58,146 - Roberta A Ballard PI) of inhaled Nitric Oxide (iNO) for the prevention of Chronic Lung Disease in preterm ventilated infants
- gestational age between 24 months and 27 months
Exclusion
- history of allergy to sedation agents
- medical conditions which may pose a threat to airway integrity (i.e., Pierre-Robin sequence, intercurrent respiratory illness)
- other conditions which may otherwise place subjects at increased risk for complications from sedation and MRI examination
Key Trial Info
Start Date :
January 1 2005
Trial Type :
OBSERVATIONAL
End Date :
March 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00153855
Start Date
January 1 2005
End Date
March 1 2006
Last Update
September 8 2006
Active Locations (3)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
2
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104