Utilization of Near-Infrared Spectroscopy Technology to Determine Normative Cerebral Regional Oxygen Saturation in a Preterm Population Born at Altitude

University of New Mexico1 site in 1 country21 target enrollmentOctober 1, 2021

ConditionsPrematurity; Extreme

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prematurity; Extreme
Sponsor: University of New Mexico
Enrollment: 21
Locations: 1
Primary Endpoint: Cerebral Regional Oxygen Saturation (cRSO2)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 1, 2021

End Date

June 30, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of New Mexico

Responsible Party

Principal Investigator

Jessie R. Maxwell

Assistant Professor of Pediatrics and Neurosciences

University of New Mexico

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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 Outcomes

Incidence of Major Complications of Prematurity(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.)