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NCT00926770 Clinical Trial

Cerebral Near Infrared Spectroscopy During Blood Sampling From a Peripheral Artery Catheter in Preterm Infants

Prematurity Clinical Trial

Official title:
Measurement of Cerebral Oxygenation With Near Infrared Spectroscopy During Blood Sampling From a Peripheral Artery Catheter in Preterm Infants With Gestational Age <37+0

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00926770
Other study ID # 06-131
Secondary ID
Status Recruiting
Phase N/A
First received June 23, 2009
Last updated June 23, 2009
Start date November 2008

Study information
Verified date June 2009
Source University of Cologne
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

Preterm infants often need peripheral artery catheters for invasive blood pressure recording and to facilitate blood sampling. Near infrared spectroscopy is a method to evaluate cerebral oxygenation and as well as cerebral blood flow. Sampling procedures with identical sampling volumes are performed at a short (40 seconds) and a long (70 seconds) time intervall while changes of cerebral oxygenation are measured. The investigators hypothesise that slower sampling decrease changes in cerebral blood flow.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 7 Days
Eligibility Inclusion Criteria:

- Preterm infant (Gestational Age <37+0)

- Peripheral arterial catheter (ulnary or radial artery)

Exclusion Criteria:

- Complex organ malformation

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany University of Cologne, NICU Cologne NRW

Sponsors (1)
Lead Sponsor Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

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