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Completed

NCT Number: NCT02147769

Cerebral Oxygenation and Autoregulation in Preterm Infants

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.

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Key information

Conditions

Intraventricular Hemorrhage of Prematurity Complications of Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 24 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIRS monitoring

Device

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

Primary outcomes

  1. Mortality Before Hospital Discharge

    Time frame: 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.

  2. Severe Central Nervous System (CNS) Morbidity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Medtronic - MITG

Registry information

Official study title

Cerebral Oxygenation and Autoregulation in Preterm Infants: Association With Morbidity and Mortality

Acronym: Early NIRS

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
May 28, 2014
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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