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Measurement of the Effect of Positional Changes on Cerebral Oxygenation in Preterm Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01255189
First Posted: December 7, 2010
Last Update Posted: August 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital
  Purpose
Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral oxygenation in newborn infants. Using this technique we investigated the effect of positional changes on cerebral oxygenation in preterm infants.

Condition Intervention Phase
pOSitional Changes of Premature Infants Device: Device: near infrared spectroscopy: INVOS 5100 Device: invos 5100 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Measurement of the Effect of Positional Changes on Cerebral Oxygenation in Preterm Infants: A Near Infrared Spectroscopy Study

Further study details as provided by Zekai Tahir Burak Women's Health Research and Education Hospital:

Primary Outcome Measures:
  • The effect of positional changes on cerebral oxygenation in preterm infants [ Time Frame: 6 months ]

Estimated Enrollment: 30
Study Start Date: December 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device: near infrared spectroscopy: invos 5100
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
Device: Device: near infrared spectroscopy: INVOS 5100
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.
Other Name: invos 5100
Device: invos 5100
near infrared spectroscopy: invos 5100

Detailed Description:
The changes in cerebral perfusion have an important role on the development of intraventricular hemorrhage and periventricular leucomalacia. Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral oxygenation in newborn infants. Using this technique we investigated the effect of positional changes on cerebral oxygenation in preterm infants.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. <32 gestational age and/or <1500gr.
  2. >30th day preterm infants

Exclusion Criteria:

  1. sepsis
  2. shock
  3. severe intracranial hemorrhage
  4. NEC
  5. abdominal and cranial surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255189


Locations
Turkey
Gamze Demirel
Ankara, Turkey
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gamze Demirel, Neonatal Intensive Care Unit ( Zekai Tahir Burak Maternity and Teaching Hospital )
ClinicalTrials.gov Identifier: NCT01255189     History of Changes
Other Study ID Numbers: 3498
First Submitted: December 2, 2010
First Posted: December 7, 2010
Last Update Posted: August 9, 2011
Last Verified: December 2010

Keywords provided by Zekai Tahir Burak Women's Health Research and Education Hospital:
NIRS