Cerebral Oxygenation and Autoregulation in Preterm Infants

Study Overview
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Brief Summary
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Premature infants are at high risk for variations in blood pressure and oxygenation during the first few days of life. The immaturity of the premature brain may further predispose these infants to death or the development of neurologic problems. The relationship between unstable blood pressure and oxygen levels and brain injury has not been well elucidated. This study investigates the utility of near-infrared spectroscopy (NIRS), a non-invasive oxygen-measuring device, to identify preterm infants at highest risk for brain injury or death.

Official Title
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Cerebral Oxygenation and Autoregulation in Preterm Infants: Association With Morbidity and Mortality

Conditions
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Intraventricular Hemorrhage of Prematurity, Complications of Prematurity

Intervention / Treatment
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* Device: NIRS monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: inborn birth weight <= 1250 grams indwelling arterial catheter in place age <24 hours old Exclusion Criteria: lethal chromosomal abnormality major congenital anomaly skin integrity insufficient to allow placement of NIRS sensors decision to not provide full intensive care

Ages Eligible for Study
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Maximum Age: 24 Hours

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm infants monitored with NIRS<br>All infants enrolled in the study will be monitored with cerebral near-infrared spectroscopy (NIRS monitoring) to measure cerebral oxygenation levels in the first 96 hours of life. Mean arterial blood pressure will simultaneously be monitored. | Device: NIRS monitoring<br>* All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality Before Hospital Discharge | Participants will be followed for the outcome of death prior to hospital discharge. | Outcome measure will be assessed at the time of subject's initial discharge from the hospital (on average by 40 weeks postmenstrual age), but at a maximum of 1 year of life. | 
| Severe Central Nervous System (CNS) Morbidity | Routine cranial ultrasound obtained within the first ten days of life will be utilized to detect grade 3 or 4 intraventricular hemorrhage, periventricular leukomalacia, significant ventriculomegaly, or white matter abnormalities. | Outcome measure will be assessed on day 10 of life. Participants will be followed for neuroradiographic evidence of CNS morbidity in the first ten days of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral autoregulation, preterm, near-infrared spectroscopy