Observational Study in Preterm Infants With and Without Intracranial Hemorrhage: Longitudinal Assessment of Cerebral Oxygenation, Perfusion and Function
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracranial Hemorrhage
- Sponsor
- Nelson Claure
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Change in cerebral oxygenation
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Nelson Claure
Research Associate Professor of Pediatrics
University of Miami
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in cerebral perfusion and function(post natal weeks 4 and 8)