NCT00131859

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2004

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

August 13, 2009

Status Verified

August 1, 2009

Enrollment Period

4.2 years

First QC Date

August 18, 2005

Last Update Submit

August 12, 2009

Conditions

Brain Injury, Fetus and Neonate

Keywords

Perinatal brain injuryDiffusion-tensor imaging

Outcome Measures

Primary Outcomes (1)

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

    2 years

Secondary Outcomes (4)

  • Umbilical cord gas results

    2 years

  • Placental pathology

    2 years

  • Electronic fetal monitoring

    2 years

  • Nucleated red blood cells

    2 years

Interventions

Diffusion-tensor imagingPROCEDURE

Obtain a Diffusion tensor MRI of brain.

Also known as: No other names applicable.

Eligibility Criteria

Age23 Weeks - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Neonates \< 1500 grams, with suspected brain injury, and with severe metabolic acidosis

You may qualify if:

  • 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

You may not qualify if:

  • Major congenital malformations
  • Chromosomal abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21287-1228, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

NeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiffusion Magnetic Resonance ImagingMagnetic Resonance ImagingTomographyDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Ernest M Graham, M.D.

    Johns Hopkins Univ; Dept. of Gyn-Ob

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2005

First Posted

August 19, 2005

Study Start

October 1, 2004

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 13, 2009

Record last verified: 2009-08

Locations

US(2)