NCT01251068

Brief Summary

Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral oxygenation in newborn infants. Using this technique we investigated the relationship between changes in cerebral oxygenation and hemodynamics, and changes in some physiological variables during blood transfusion in anaemic preterm infants.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

December 7, 2010

Status Verified

November 1, 2010

Enrollment Period

6 months

First QC Date

November 30, 2010

Last Update Submit

December 6, 2010

Conditions

Keywords

anemic preterms, cerebral oxygenation,somatic oxygenation, blood transfusion

Outcome Measures

Primary Outcomes (1)

  • Cerebral and peripheric oxygenation measurements in anemic preterm infants.

    6 months

Study Arms (1)

gest age, cerebral ,somatic oxygenation measurement

EXPERIMENTAL
Device: near infrared spectroscopy: invos 5100Device: INVOS 5100Device: near infrared spectroscopy device

Interventions

duration:six hours

gest age, cerebral ,somatic oxygenation measurement

NIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, we applied NIRS probes to the forehead and the lower extremity for cerebral (rSO2C) and peripheric (rSO2P) regional oxygen saturation measurements.

gest age, cerebral ,somatic oxygenation measurement

NIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, we applied NIRS probes to the forehead and the lower extremity for cerebral (rSO2C) and peripheric (rSO2P) regional oxygen saturation measurements.

gest age, cerebral ,somatic oxygenation measurement

Eligibility Criteria

Age30 Days+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zekai Tahir Maternity Teaching Hospital

Ankara, Hamamönü, 06330, Turkey (Türkiye)

RECRUITING

Zekai Tahir Maternity Teaching Hospital

Ankara, Hamamönü, 06330, Turkey (Türkiye)

RECRUITING

Central Study Contacts

gonca sandal, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2010

First Posted

December 1, 2010

Study Start

December 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

December 7, 2010

Record last verified: 2010-11

Locations