Use of NIRS in Preterm Population Born at Altitude

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of New Mexico

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Inclusion Criteria

Infant must be <32 weeks' gestational age at time of delivery

Consenting mother/guardian of the infant must speak English

Babies who need blood transfusions during the monitoring period can still participate.

Exclusion Criteria

Infant is greater than 24 hours of age at time of consent

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)

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Treatment Details

Interventions

Near-infrared spectroscopy (NIRS) utilization (Diagnostic Device)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Observational ArmExperimental Treatment1 Intervention

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.