Measurement of the Effect of Positional Changes on Cerebral Oxygenation in Preterm Infants - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies

U.S. FDA Resources

Further study details as provided by Zekai Tahir Burak Maternity and Teaching 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

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:

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

Exclusion Criteria:

sepsis
shock
severe intracranial hemorrhage
NEC
abdominal and cranial surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255189

Locations

Turkey
Gamze Demirel
Ankara, Turkey

Sponsors and Collaborators

Zekai Tahir Burak Maternity and Teaching Hospital

More Information

No publications provided by Zekai Tahir Burak Maternity and Teaching Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Nov 15.

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 Maternity and Teaching Hospital:

NIRS

ClinicalTrials.gov processed this record on June 17, 2013