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Purpose

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.

Conditions

Eligibility

Eligible Ages
Under 24 Hours
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Preterm infants monitored with NIRS 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
    All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure.

More Details

Status
Completed
Sponsor
Stanford University

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.