Cerebral Oxygenation and Autoregulation in Preterm Infants: Association With Morbidity and Mortality
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intraventricular Hemorrhage of Prematurity
- Sponsor
- Stanford University
- Enrollment
- 111
- Locations
- 7
- Primary Endpoint
- Mortality Before Hospital Discharge
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Valerie Chock, M.D., M.S. Epi
Principle Investigator
Stanford University
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Mortality Before 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.
Participants will be followed for the outcome of death prior to hospital discharge.
Severe Central Nervous System (CNS) Morbidity
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
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.