Clinical Trial: Observational Study in Preterm Infants With Intracranial Hemorrhage
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Observational Study in Preterm Infants With and Without Intracranial Hemorrhage: Longitudinal Assessment of Cerebral Oxygenation, Perfusion and Function
Brief Summary:
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.
Detailed Summary:
Sponsor: Nelson Claure
Current Primary Outcome: Change in cerebral oxygenation [ Time Frame: postnatal weeks 4 and 8 ]
Original Primary Outcome: Progression of cerebral oxygenation [ Time Frame: postnatal weeks 1, 4 and 8 ]
Current Secondary Outcome: Change in cerebral perfusion and function [ Time Frame: post natal weeks 4 and 8 ]
Original Secondary Outcome: Progression of cerebral perfusion and function [ Time Frame: post natal weeks 1, 4 and 8 ]
Information By: University of Miami
Dates:
Date Received: June 5, 2012
Date Started: June 2012
Date Completion: December 2017
Last Updated: January 9, 2017
Last Verified: January 2017