Our objective is to use diffusion-tensor imaging (DTI) to evaluate infants diagnosed with cerebral white matter injury during the neonatal period and identify antenatal risk factors, electronic fetal heart rate monitoring abnormalities, and umbilical arterial gas results that are associated with cerebral white matter injury. Our hypothesis is that this new imaging technique will help us better understand how these devastating injuries occur.

Condition	Intervention
Perinatal brain injury	Procedure: Diffusion-tensor imaging

Further Study Details: 

Primary Outcomes: Diffusion-tensor imaging differences between brain injured cases and controls without brain injury
Secondary Outcomes: Umbilical cord gas results; Placental pathology; Electronic fetal monitoring; Nucleated red blood cells
Expected Total Enrollment:  270

Maternal and neonatal data will be collected as well as the umbilical arterial gas results and the electronic fetal heart rate tracing of the labor. Infants will have a head ultrasound at 24-72 hours, 10-14 days, and at 4-6 weeks to look for cerebral white matter injury, as standard of care. All infants with a birth weight < 1500 grams will be offered DTI, and infants > 1500 grams with white matter injury diagnosed by ultrasound will be imaged as well as the subsequent delivery born within 7 days of that gestational age without brain injury. All infants will have the DTI brain scan at 12-18 months of age corrected for the degree of prematurity, and will also have a formal neurological assessment at that time.

Ages Eligible for Study:  40 Weeks   -   18 Months,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• All infants born at our hospital at < 1500 grams
• All infants born at our hospital at > 1500 grams with brain injury or severe metabolic acidosis

Exclusion Criteria:

• Major congenital malformations
• Chromosomal abnormality

Please refer to this study by ClinicalTrials.gov identifier  NCT00131859

Ernest M Graham, M.D.      410-955-5850    egrahaa@jhmi.edu

Maryland
      Johns Hopkins Hospital, Baltimore,  Maryland,  21287,  United States; Recruiting

Study chairs or principal investigators

Ernest M Graham, M.D.,  Principal Investigator,  Johns Hopkins Univ; Dept. of Gyn-Ob   

Study ID Numbers:  04-08-31-01
Last Updated:  August 18, 2005
Record first received:  August 18, 2005
ClinicalTrials.gov Identifier:  NCT00131859
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23