Observational Study in Preterm Infants With Intracranial Hemorrhage



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:1/18/2019
Start Date:June 2012
End Date:December 2020
Contact:Nelson Claure, M.Sc., Ph.D.
Email:nclaure@miami.edu
Phone:3055856408

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Trial Summary
Trial Overview
Inclusion Criteria

Observational Study in Preterm Infants With and Without Intracranial Hemorrhage: Longitudinal Assessment of Cerebral Oxygenation, Perfusion and Function

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.


Inclusion Criteria:

- Preterm infants born between 23 and 28 weeks of gestation

- Diagnosed with ICH grades II or higher during the first week after birth

- Matched control infants without ICH.

Exclusion Criteria:

- Major congenital malformations

- Birth asphyxia

- Not expected to survive
We found this trial at
1
site
Holtz Children's Hospital, Jackson Memorial Hospital/University of Miami Medical Center
Miami, Florida 33136
?
mi
from
Miami, FL
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