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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Matched group of control infants without diagnosis of intracranial hemorrhage |
| |
| Intracranial Hemorrhage | Group of preterm infant with diagnosis of intracranial hemorrhage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention/treatment is given | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cerebral oxygenation | Comparison of the progression of cerebral oxygenation measured non-invasively by near infrared spectroscopy over time in infants with ICH and non-ICH infants. | postnatal weeks 4 and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cerebral perfusion and function | 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. | post natal weeks 4 and 8 |
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Inclusion Criteria:
Exclusion Criteria:
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Preterm infants admitted to the newborn intensive care unit at Holtz Children's Hospital of the Jackson Memorial Hospital/University of Miami Medical Center.
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| Name | Affiliation | Role |
|---|---|---|
| Nelson Claure, M.Sc.,Ph.D. | University of Miami | Principal Investigator |
| Eduardo Bancalari, M.D. | University of Miami | Principal Investigator |
| Deepak Jain, M.D. | University of Miami | Principal Investigator |
| Sethuraman Swaminathan, M.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holtz Children's Hospital, Jackson Memorial Hospital/University of Miami Medical Center | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002534 | Hypoxia, Brain |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |