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NCT00932633 · ClinicalTrials.gov registry record

Magnetic Resonance Imaging (MRI) to Evaluate Brain Injury in Congenital Heart Disease

A clinical trial, sponsored by Emory University.

Completed
Registry status
92
Enrollment target

NCT00932633: Completed study, sponsored by Emory University.

NCT00932633 is a clinical trial that has completed, run by Emory University. The registered enrollment target is 92 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00932633 has completed, sponsored by Emory University.

COMPLETED
Registry status
92 participants
Enrollment target

Study Summary

Infants with congenital heart disease (CHD) requiring surgery frequently have brain injury seen on magnetic resonance imaging (MRI). This occurs in approximately 40% of these newborns, and even though these are full-term infants, the injury seen closely resembles the same form of brain injury that can be seen in premature babies. Much like premature newborns, infants with CHD also have long-term neurodevelopmental problems (in over 50%). The investigators do not know why infants with CHD get this specific form of brain injury. One risk factor is felt to be the inflammation that occurs in response to heart-lung bypass (cardiopulmonary bypass, or CPB), a necessary feature of open-heart surgery. Newborns have a stronger inflammatory reaction to CPB than older children or adults. The investigators do know from animal experiments and other human data that inflammation can be harmful to the developing brain. The investigators hypothesize that children with CHD requiring surgery as a newborn have brain injury due to toxicity from the inflammatory response. The investigators will test this by enrolling newborns undergoing heart surgery to measure markers of inflammation, measure brain injury by MRI, and then test their developmental outcome at 1 and 2 years of age. An association between inflammation and injury might impact what medicines are chosen to protect the brain in future studies, even in other populations such as preterm infants.

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2009-08
Est. Completion 2016-01
Emory University

1,208 total trials

What the finished NCT00932633 record still lists

NCT00932633 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 92 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT00932633 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00932633 about?

NCT00932633 is a clinical study titled "Magnetic Resonance Imaging (MRI) to Evaluate Brain Injury in Congenital Heart Disease". Infants with congenital heart disease (CHD) requiring surgery frequently have brain injury seen on magnetic resonance imaging (MRI). This occurs in approximately 40% of these newborns, and even though these are full-term infants, the injury seen closely resembles the same form of brain injury that c...

What is the current status of trial NCT00932633?

This trial is currently completed. The enrollment target is 92 participants. The study started on 2009-08. Estimated completion is 2016-01.

Who is sponsoring clinical trial NCT00932633?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00932633, the US trial registry maintained by the National Library of Medicine. NCT00932633 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.