Observational Study in Preterm Infants With Intracranial Hemorrhage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2023-11-01

Brief Summary

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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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Detailed Description

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Conditions

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Intracranial Hemorrhage Intraventricular Hemorrhage Cerebral Hypoxia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Matched group of control infants without diagnosis of intracranial hemorrhage

No intervention/treatment is given

Intervention Type OTHER

Intracranial Hemorrhage

Group of preterm infant with diagnosis of intracranial hemorrhage.

No intervention/treatment is given

Intervention Type OTHER

Interventions

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No intervention/treatment is given

Intervention Type OTHER

Eligibility Criteria

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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.