An observational study in Intracranial Hemorrhage, Intraventricular Hemorrhage and Cerebral Hypoxia, sponsored by Nelson Claure. Completed at 1 site in United States. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Nelson Claure · Observational
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.
211 studies on the registry are indexed under Intracranial Hemorrhages; 62 are open to participants now.
This study's enrollment of 27 is below the median of 250 across 85 observational studies indexed under Intracranial Hemorrhages.
Browse Intracranial Hemorrhages studies →This is the only study on the registry with Nelson Claure as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Preterm infants admitted to the newborn intensive care unit at Holtz Children's Hospital of the Jackson Memorial Hospital/University of Miami Medical Center.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Matched group of control infants without diagnosis of intracranial hemorrhage
Other: No intervention/treatment is given
Group of preterm infant with diagnosis of intracranial hemorrhage.
Other: No intervention/treatment is given
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.
Time frame: postnatal weeks 4 and 8
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.
Time frame: post natal weeks 4 and 8
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2012 to primary completion in Nov 2023, 137 months.
Of 44 non-industry observational studies under Intracranial Hemorrhages, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 130. This study's 137 months is above that.
Counting every sponsor, half of 49 studies reached it within 59 months; a quarter within 21 and three quarters within 105.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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