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

This study has been completed.
Sponsor:
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier:
NCT01255189
First received: December 2, 2010
Last updated: August 5, 2011
Last verified: December 2010
  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: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 2 Months
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01255189

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

No publications provided by Zekai Tahir Burak Women's Health Research and Education Hospital

Additional 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
Study First Received: December 2, 2010
Last Updated: August 5, 2011
Health Authority: Turkey: Ethics Committee

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

ClinicalTrials.gov processed this record on October 23, 2014