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Completed

NCT Number: NCT00131859

Diffusion-Tensor Magnetic Resonance Imaging (MRI) and the Evaluation of Perinatal Brain Injury

The researchers' 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. The researchers' hypothesis is that this new imaging technique will help us better understand how these devastating injuries occur.

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Key information

Conditions

Brain Injury, Fetus and Neonate Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

23 week–18 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Hospital, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diffusion-tensor imaging

Procedure

Obtain a Diffusion tensor MRI of brain.

Other names: No other names applicable.

Primary outcomes

  1. Diffusion-tensor imaging differences between brain injured cases and controls without brain injury

    Time frame: 2 years

Secondary outcomes

  1. Umbilical cord gas results

    Time frame: 2 years

  2. Placental pathology

    Time frame: 2 years

  3. Electronic fetal monitoring

    Time frame: 2 years

  4. Nucleated red blood cells

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Registry information

Official study title

Diffusion-Tensor Magnetic Resonance Imaging and the Evaluation of Perinatal Brain Injury

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Aug 19, 2005
Registry last updated
Aug 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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