Measurement of Cerebral Oxygenation Using NIRS Method in the Preterm Infants With Intracranial Haemorrhagia

NCT ID: NCT01266889

Last Updated: 2010-12-24

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

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-05-31

Brief Summary

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The aim of the study was investigated the cerebral tissue oxygenation index (c-TOI) measured by near infrared spectroscopy (NIRS)in the preterm infants with intracranial haemorrhagia.

Detailed Description

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Conditions

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Cerebral Oxygenation, Intracranial Haemorrhagia

Keywords

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preterm infant,cerebral oxygenation, intracranial haemorrhagia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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study group, control group

device:INVOS 5100

Intervention Type DEVICE

Continuous wave NIRS is a method for measurement of cerebral oxygenation and haemodynamics. This method is non-invasive, continuous, and can also be used as bedside monitoring. With continuous wave NIRS only changes in concentration of oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb) can be measured, not the absolute level of these parameters. It has been shown that changes in concentration of HbD (O2Hb - HHb) reflect changes in CBF. So, continuous monitoring of changes in concentration of HbD can be used as an indicator of changes in CBF, but changes in CBV will also influence the HbD signal, as will changes in arterial O2 saturation (saO2) and changes in cerebral metabolic rate for oxygen.

Interventions

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device:INVOS 5100

Continuous wave NIRS is a method for measurement of cerebral oxygenation and haemodynamics. This method is non-invasive, continuous, and can also be used as bedside monitoring. With continuous wave NIRS only changes in concentration of oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb) can be measured, not the absolute level of these parameters. It has been shown that changes in concentration of HbD (O2Hb - HHb) reflect changes in CBF. So, continuous monitoring of changes in concentration of HbD can be used as an indicator of changes in CBF, but changes in CBV will also influence the HbD signal, as will changes in arterial O2 saturation (saO2) and changes in cerebral metabolic rate for oxygen.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

.\<34 gestation week preterm infants with intracranial haemorrhagia

Exclusion Criteria

* sepsis
* NEC
* congenital abnormalities
* hydrocephalus
* intracranial infections
Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zekai Tahir Burak Maternity and Teaching Hospital

Locations

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Melek Akar

Ankara, Hamamönü, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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ugur dilmen, proff

Role: CONTACT

Phone: +90 312 506 5270

Email: [email protected]

Facility Contacts

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melek akar, M.D

Role: primary

Other Identifiers

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3

Identifier Type: -

Identifier Source: org_study_id