Use of NIRS in Preterm Population Born at Altitude

Overview

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

  • 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

Interventions

  • 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

Primary 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.

Secondary Measures

  • 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

Inclusion Criteria

  • Infant must be <32 weeks' gestational age at time of delivery. – Consenting mother/guardian of the infant must speak English. Other languages are not being included due to the need of a translator being brought into the unit, which adds risk to the vulnerable population. Additionally, as the time to consent is a narrow window, adding the complexity of getting a translator may delay the ability to get consent and thus make it more difficult to enroll patients. – Infants that require blood transfusions during the monitoring time may be included. Exclusion Criteria:
  • Any known cardiac anomaly or other anomaly which may impair perfusion and blood flow. – Infant born after placental abruption or concern for extreme blood loss immediately after birth. – Unable to consent the mother/guardian due to maternal health issues after delivering (eg requiring intubation or sedation after the delivery). – Mothers/guardians that are prisoners, as the study team would like to have continuing communication with the mother during the study period as needed. – Mothers/guardians that are <18 years of age will not be approached for consent. – Any mother/guardian that is not able to consent due to having a legal representative will not be approached for consent in this study. – Any infant that is planned to be placed for adoption – Infant is greater than 24 hours of age at time of consent.
  • Gender Eligibility: All

    Minimum Age: N/A

    Maximum Age: 24 Hours

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • 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, jrmaxwell@salud.unm.edu

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