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 ]

Comparison of the progression of cerebral oxygenation measured non-invasively by near infrared spectroscopy over time in infants with ICH and non-ICH infants.


Original Primary Outcome: Progression of cerebral oxygenation [ Time Frame: postnatal weeks 1, 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.


Current Secondary Outcome: 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.


Original Secondary Outcome: Progression of cerebral perfusion and function [ Time Frame: post natal weeks 1, 4 and 8 ]

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.


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