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Aneurysms and Carotid Artery Block in Newborns

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00646672
First received: March 26, 2008
Last updated: April 17, 2010
Last verified: April 2010

March 26, 2008
April 17, 2010
March 2008
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Complete list of historical versions of study NCT00646672 on ClinicalTrials.gov Archive Site
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Aneurysms and Carotid Artery Block in Newborns
Assessment of Cerebral Circulation and Perfusion in Adults After Neonatal Carotid Occlusion

This study will determine the risk of brain aneurysm (abnormal outpouching of a brain artery) in young adults who had their carotid artery tied off as an infant as part of the extracorporeal membrane oxygenation (ECMO) procedure. This procedure is sometimes performed on newborns with lung problems so that they can have oxygen brought to their blood outside the body. ECMO operates similar to a heart-lung machine. Blood drained from the veins has the carbon dioxide removed and oxygen added. The oxygenated blood is then returned to the body through the arteries.

People 18 to 25 years of age who underwent ECMO as an infant at the Children's National Medical Center in Washington, D.C., may be eligible for this study.

Participants undergo the following procedures:

  • Medical history and physical and neurological examinations.
  • Magnetic resonance imaging (MRI) of the head and neck. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The subject lies in the scanner (a metal cylinder surrounded by a magnetic field) for about 90 minutes, lying still for up to 15 minutes at a time. During part of the procedure, a contrast dye is injected into a vein through a catheter (thin plastic tube) to enhance the images.

Objective:

To assess whether the hemodynamic stress of long-term common carotid artery occlusion can lead to cerebral aneurysm formation in young adults.

Study population:

100 adults 18-25 years of age who underwent common carotid artery (CCA) occlusion as a neonate as part of the extracorporeal membrane oxygenation (ECMO) procedure performed in the setting of pulmonary insufficiency.

Design:

Patients who underwent CCA occlusion as a neonate for ECMO at Children's National Medical Center will be identified and contacted. The study will be explained and informed consent will be obtained. Subjects will undergo outpatient evaluation to include history and physical, magnetic resonance angiography and magnetic resonance imaging of the head.

Outcome measures:

  • Cerebrovascular anatomic anomalies such as cerebral aneurysms and persistent fetal circulation pathways, etc.
  • Cerebral perfusion asymmetry on MRI.
  • Cerebral parenchymal abnormalities such as stroke.
Observational
Time Perspective: Retrospective
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Cerebrovascular Disorder
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
April 2010
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  • INCLUSION CRITERIA:

Subjects must be 18-25 years of age.

Subjects had VA ECMO as a neonate at Children's National Medical Center.

Subjects must be in good health.

Subjects must provide informed, written consent for participation in this study.

EXCLUSION CRITERIA:

Subjects with a history or evidence of mental retardation precluding a written consent unless this consent could be obtained from a legal guardian.

Subjects with a history of reaction to MR contrast media or who are unable to have an MRI.

Subjects who underwent carotid artery reconstruction after neonatal ECMO.

Females who are pregnant or nursing.

Both
18 Years to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00646672
080095, 08-N-0095
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National Institute of Neurological Disorders and Stroke (NINDS)
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National Institutes of Health Clinical Center (CC)
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP