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

NCT ID: NCT01255189

Last Updated: 2011-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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pOSitional Changes of Premature Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Device: near infrared spectroscopy: INVOS 5100

Intervention Type DEVICE

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.

invos 5100

Intervention Type DEVICE

near infrared spectroscopy: invos 5100

Interventions

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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.

Intervention Type DEVICE

invos 5100

near infrared spectroscopy: invos 5100

Intervention Type DEVICE

Other Intervention Names

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invos 5100

Eligibility Criteria

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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
Minimum Eligible Age

3 Days

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role lead

Responsible Party

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Neonatal Intensive Care Unit ( Zekai Tahir Burak Maternity and Teaching Hospital )

Locations

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Gamze Demirel

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 22088784 (View on PubMed)

Other Identifiers

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3498

Identifier Type: -

Identifier Source: org_study_id

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