Measurement of the Effect of Positional Changes on Cerebral Oxygenation in Preterm Infants
1 other identifier
interventional
30
1 country
1
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 effect of positional changes on cerebral oxygenation in preterm infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2010
Shorter than P25 for phase_4
1 active site
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
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 2, 2010
CompletedFirst Posted
Study publicly available on registry
December 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedAugust 9, 2011
December 1, 2010
6 months
December 2, 2010
August 5, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The effect of positional changes on cerebral oxygenation in preterm infants
6 months
Study Arms (1)
Device: near infrared spectroscopy: invos 5100
EXPERIMENTALNIRS 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
Interventions
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.
near infrared spectroscopy: invos 5100
Eligibility Criteria
You may qualify if:
- \<32 gestational age and/or \<1500gr.
- \>30th day preterm infants
You may not qualify if:
- sepsis
- shock
- severe intracranial hemorrhage
- NEC
- abdominal and cranial surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gamze Demirel
Ankara, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 22088784DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 2, 2010
First Posted
December 7, 2010
Study Start
December 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
August 9, 2011
Record last verified: 2010-12