CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 111 enrolled
Drug / intervention
NIRS monitoringdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02147769
NCT02147769N/ACompleted
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Cerebral Oxygenation and Autoregulation in Preterm Infants: Association With Morbidity and Mortality

Stanford University·observational·Posted May 28, 2014·Updated Apr 7, 2020

In Brief

An observational study evaluating NIRS monitoring for Intraventricular Hemorrhage of Prematurity and Complications of Prematurity. Completed, enrolled 111 participants across 7 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsIntraventricular Hemorrhage of Prematurity, Complications of Prematurity
CountriesUnited States
CollaboratorsMedtronic - MITG

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 28, 2014
Enrollment StartMay 1, 2014
Primary CompletionDec 1, 2017
Study CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 12.1 years ago

Interventions

NIRS monitoringdevice

All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure.