Observational Study in Preterm Infants With Intracranial Hemorrhage

Nelson Claure

Status: Completed

Conditions: Intraventricular Hemorrhage; Intracranial Hemorrhage; Cerebral Hypoxia

Treatments: Other: No intervention/treatment is given

Study type: Observational

Funder types: Other

Identifiers

NCT01620203

20120065

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

27 participants in 2 patient groups

Control

Description:

Matched group of control infants without diagnosis of intracranial hemorrhage

Treatment:

Other: No intervention/treatment is given

Intracranial Hemorrhage

Description:

Group of preterm infant with diagnosis of intracranial hemorrhage.

Treatment:

Other: No intervention/treatment is given