Cerebral Oxygenation and Autoregulation in Preterm Infants

Stanford University111 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

111

Conditions

Intraventricular Hemorrhage of Prematurity Complications of Prematurity

Interventions

NIRS monitoringDEVICE

All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure.

Eligibility

Sex: ALLMax age: 24 Hours

Medical Language ↔ Plain English

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

Locations (7)

University of Alabama

Birmingham, Alabama, United States

Stanford University

Palo Alto, California, United States

Santa Clara Valley Medical Center

San Jose, California, United States

Yale-New Haven Children's Hospital

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Mortality Before Hospital Discharge

Participants will be followed for the outcome of death prior to hospital discharge.

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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