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Cerebral Oxygenation and Autoregulation in Preterm Infants

Completed
Conditions
Complications of Prematurity
Intraventricular 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
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

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Severe Central Nervous System (CNS) MorbidityOutcome 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 DischargeOutcome 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
NameTimeMethod

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

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