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

Study Overview
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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.

Official Title
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Measurement of the Effect of Positional Changes on Cerebral Oxygenation in Preterm Infants: A Near Infrared Spectroscopy Study

Conditions
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pOSitional Changes of Premature Infants

Intervention / Treatment
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* Device: Device: near infrared spectroscopy: INVOS 5100
* Device: invos 5100


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: <32 gestational age and/or <1500gr. >30th day preterm infants Exclusion Criteria: sepsis shock severe intracranial hemorrhage NEC abdominal and cranial surgery

Ages Eligible for Study
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Minimum Age: 3 Days
Maximum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device: near infrared spectroscopy: invos 5100<br>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<br>* 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.<br>* Other names: invos 5100;Device: invos 5100<br>* near infrared spectroscopy: invos 5100<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of positional changes on cerebral oxygenation in preterm infants |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NIRS