Cerebral Oxygenation and Autoregulation in Preterm Infants

Completed

• Conditions: Complications of Prematurity; Intraventricular Hemorrhage of Prematurity
• Interventions: Device: NIRS monitoring

• 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

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-22
• Study First Posted: 2014-05-28
• Primary Completion: 2017-12
• Study Completion: 2018-03
• Results First Submitted: 2020-03-21
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-05
• Last Update Submitted: 2020-04-05
• Results First Posted: 2020-04-07
• Last Update Posted: 2020-04-07

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

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Exclusion Criteria

• lethal chromosomal abnormality
• major congenital anomaly
• skin integrity insufficient to allow placement of NIRS sensors
• decision to not provide full intensive care

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preterm infants monitored with NIRS	NIRS monitoring	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (7)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Santa Clara Valley Medical Center; 🇺🇸 San Jose, California, United States

Yale-New Haven Children's Hospital; 🇺🇸 New Haven, Connecticut, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

St. John's Children's Hospital; 🇺🇸 Springfield, Illinois, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States