Cerebral Oxygenation and Autoregulation in Preterm Infants (Early NIRS)

Stanford University

Status: Completed

Conditions: Intraventricular Hemorrhage of Prematurity; Complications of Prematurity

Treatments: Device: NIRS monitoring

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02147769

23894

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: Under 24 hours old

Volunteers: No Healthy Volunteers

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

Trial design

111 participants in 1 patient group

Preterm infants monitored with NIRS

Description:

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.

Treatment:

Device: NIRS monitoring