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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01898650
Other study ID # 201208086
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 30, 2013
Est. completion date July 2017

Study information

Verified date May 2023
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Craniosynostosis is a birth defect that causes the bones on a baby's head to fuse together earlier than normal. This causes the baby to have an abnormally shaped head. These children are operated on to prevent or treat increased pressure on the brain, allowing for normal development. There is not good evidence of which children with craniosynostosis have increased pressure on the brain. Up to twenty patients with craniofacial abnormalities will be enrolled in this pilot study. The investigators will use a magnetic resonance scanner to obtain several measures of brain metabolism. The investigators will also obtain data which are markers of developmental delay. The results will also be compared to age and gender matched data from children without craniofacial abnormalities. There study hypothesis is that patients with craniofacial abnormalities associated with intracranial pressure will have decreased metabolic activity compared to control patients.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
MR scan


Locations

Country Name City State
United States St. Louis Children's Hospital Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood Flow and Perfusion To be measured with both oxygen extraction fraction and arterial spin labeling to measure blood flow. during the single MRI scan, approximately 30 - 45 minutes
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