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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01620203
Other study ID # 20120065
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2012
Est. completion date November 1, 2023

Study information

Verified date November 2023
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date November 1, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Day to 28 Days
Eligibility 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

Study Design


Intervention

Other:
No intervention/treatment is given


Locations

Country Name City State
United States Holtz Children's Hospital, Jackson Memorial Hospital/University of Miami Medical Center Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
Nelson Claure

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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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