Near-infrared spectroscopy (NIRS), is a technology that can provide continuous, non-invasive monitoring of oxygenation in tissue. The objective of this study is to obtain the cerebral regional oxygen saturation (cRSO2) in a preterm population that is born at altitude to determine if the range of "normal" values is different than those obtained at sea level.
Full Title of Study: “Utilization of Near-Infrared Spectroscopy Technology to Determine Normative Cerebral Regional Oxygen Saturation in a Preterm Population Born at Altitude”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Supportive Care
- Masking: None (Open Label)
- Study Primary Completion Date: July 2022
- Device: Near-infrared spectroscopy (NIRS) utilization
- The NIRS devise will be applied so that cerebral regional oxygen saturation (cRSO2) can be measured.
Arms, Groups and Cohorts
- Experimental: Observational Arm
- Any infant consented to participate in the study will have the NIRS applied for the first 96 hours of life. It will be the goal to apply the NIRS sensors in the first 12 hours of life. All infants will have the same treatment if in the study, but clinicians will not be able to see the data obtained so that there is no clinical interpretation during this time.
Clinical Trial Outcome Measures
- cerebral regional oxygen saturation (cRSO2)
- Time Frame: first 96 hours of life
- Measure cRSO2 for the first 96 hours of life in infants born preterm.
- Incidence of Major Complications of Prematurity
- Time Frame: From birth until the end of the birth hospitalization, which would be discharge home or death, whichever occurs first. Estimated time is up to 6 months of age.
- Additional items recorded to determine if there is any correlation with the cRSO2 values, including death, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, duration of supplemental oxygen required, time to taking full volume feeds via nippling, and hospital length of stay.
Participating in This Clinical Trial
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: 24 Hours
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of New Mexico
- Provider of Information About this Clinical Study
- Principal Investigator: Jessie R. Maxwell, Assistant Professor of Pediatrics and Neurosciences – University of New Mexico
- Overall Contact(s)
- Jessie R Maxwell, MD, 6308649422, firstname.lastname@example.org
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