Observational Study in Preterm Infants With Intracranial Hemorrhage

N/ACompletedNCT01620203

Nelson Claure27 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Intracranial Hemorrhage Intraventricular Hemorrhage Cerebral Hypoxia

Interventions

No intervention/treatment is given

Eligibility

Sex: ALLMin age: 1 DayMax age: 28 Days

Medical Language ↔ Plain English

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

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

Secondary Outcomes

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