Structural Brain Abnormalities in Children Born Prematurely: New Detection Methods and Clinical-Pathological Correlates

Stopped early

Conditions studied: Infant, Premature, Brain Injuries

In brief

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.

Key facts

Study ID: NCT00153855
Run by: Children's Hospital of Philadelphia
People needed: 50
Starts: 2005-01-01
Expected to finish: 2006-03-01
Last updated by the study team: 2006-09-08

Who can join

Age: 2 and older, up to 2. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Children's Hospital Boston — Boston, Massachusetts, United States
Children's Mercy Hospital — Kansas City, Missouri, United States
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.