Cerebral Oxygenation and Autoregulation in Preterm Infants
- Conditions
- Complications of PrematurityIntraventricular Hemorrhage of Prematurity
- Registration Number
- NCT02147769
- Lead Sponsor
- Stanford University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
- inborn
- birth weight <= 1250 grams
- indwelling arterial catheter in place
- age <24 hours old
- lethal chromosomal abnormality
- major congenital anomaly
- skin integrity insufficient to allow placement of NIRS sensors
- decision to not provide full intensive care
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severe Central Nervous System (CNS) Morbidity 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.
Mortality Before 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. Participants will be followed for the outcome of death prior to hospital discharge.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- 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
St. John's Children's Hospital
🇺🇸Springfield, Illinois, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
University of Alabama🇺🇸Birmingham, Alabama, United States