Observational Study in Preterm Infants With Intracranial Hemorrhage
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Observational Study in Preterm Infants With and Without Intracranial Hemorrhage: Longitudinal Assessment of Cerebral Oxygenation, Perfusion and Function|
- Progression of cerebral oxygenation [ Time Frame: postnatal weeks 1, 4 and 8 ] [ Designated as safety issue: No ]Comparison of the progression of cerebral oxygenation measured non-invasively by near infrared spectroscopy over time in infants with ICH and non-ICH infants.
- Progression of cerebral perfusion and function [ Time Frame: post natal weeks 1, 4 and 8 ] [ Designated as safety issue: No ]Comparisons of ultrasound measurements of superior vena cava flow, brain electrical activity by electroencephalography and auditory brainstem responses over time in infants with ICH and non-ICH infants.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Matched group of control infants without diagnosis of intracranial hemorrhage
Group of preterm infant with diagnosis of intracranial hemorrhage.
Please refer to this study by its ClinicalTrials.gov identifier: 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:||Nao Sasaki, M.D.||University of Miami|