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CompletedNCT01255189Updated Aug 9, 2011

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

A Phase 4 interventional study of Device: near infrared spectroscopy: INVOS 5100 and invos 5100 in pOSitional Changes of Premature Infants, sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital. Completed at 1 site in Turkey. Open to participants aged 3 Days to 2 Months. Per ClinicalTrials.gov, last updated 2011-08-09.

Sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
3 Days to 2 Months
Sex
All
01

Study 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 effect of positional changes on cerebral oxygenation in preterm infants.

Read the 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.

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Conditions studied

  • pOSitional Changes of Premature Infants

Keywords

  • NIRS
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In context

Lead sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital is the lead sponsor of 62 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Days to 2 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. sepsis
  2. shock
  3. severe intracranial hemorrhage
  4. NEC
  5. abdominal and cranial surgery
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Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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 · Device: invos 5100

Interventions

  • DeviceDevice: 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.

    Also known as: invos 5100

  • Deviceinvos 5100

    near infrared spectroscopy: invos 5100

06

What researchers measure

Primary outcomes

  1. The effect of positional changes on cerebral oxygenation in preterm infants

    Time frame: 6 months

07

Study locations

1 site
  • Gamze Demirel
    Ankara, Turkey
08

References and documents

Publications

  • Demirel G, Oguz SS, Celik IH, Erdeve O, Dilmen U. Cerebral and mesenteric tissue oxygenation by positional changes in very low birth weight premature infants. Early Hum Dev. 2012 Jun;88(6):409-11. doi: 10.1016/j.earlhumdev.2011.10.005. Epub 2011 Nov 15. PubMed 22088784 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01255189
Lead sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
First posted
Dec 7, 2010
Start date
Dec 2010
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Aug 9, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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