Observational Study in Preterm Infants With Intracranial Hemorrhage
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|ClinicalTrials.gov Identifier: NCT01620203|
Recruitment Status : Recruiting
First Posted : June 15, 2012
Last Update Posted : May 1, 2018
Intracranial Hemorrhage (ICH) is an important morbidity affecting premature infants and can have considerable effects on neurodevelopmental outcome.
The investigators showed that preterm infants with severe ICH have decreased cerebral oxygenation several weeks after the hemorrhage. The mechanisms involved in this state of decreased cerebral oxygenation in preterm infants and the effects on cerebral function are unknown.
This longitudinal observation study will evaluate physiologic parameters to determine trends in cerebral oxygenation and function in preterm infants with ICH in comparison to infants without ICH.
|Condition or disease|
|Intracranial Hemorrhage Intraventricular Hemorrhage Cerebral Hypoxia|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Observational Study in Preterm Infants With and Without Intracranial Hemorrhage: Longitudinal Assessment of Cerebral Oxygenation, Perfusion and Function|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Matched group of control infants without diagnosis of intracranial hemorrhage
Group of preterm infant with diagnosis of intracranial hemorrhage.
- Change in cerebral oxygenation [ Time Frame: postnatal weeks 4 and 8 ]Comparison of the progression of cerebral oxygenation measured non-invasively by near infrared spectroscopy over time in infants with ICH and non-ICH infants.
- Change in cerebral perfusion and function [ Time Frame: post natal weeks 4 and 8 ]Comparisons of ultrasound measurements of superior vena cava flow and brain electrical activity by electroencephalography over time in infants with ICH and non-ICH infants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620203
|Contact: Nelson Claure, M.Sc., Ph.D.||firstname.lastname@example.org|
|Contact: Carmen D'Ugard, M.D., R.R.T.||email@example.com|
|United States, Florida|
|Holtz Children's Hospital, Jackson Memorial Hospital/University of Miami Medical Center||Recruiting|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Nelson Claure, M.Sc.,Ph.D.||University of Miami|
|Principal Investigator:||Eduardo Bancalari, M.D.||University of Miami|
|Principal Investigator:||Deepak Jain, M.D.||University of Miami|
|Principal Investigator:||Sethuraman Swaminathan, M.D.||University of Miami|