Use of NIRS in Preterm Population Born at Altitude

University of New Mexico (UNM)

Status: Completed

Conditions: Prematurity; Extreme

Treatments: Device: Near-infrared spectroscopy (NIRS) utilization

Study type: Interventional

Funder types: Other

Identifiers

NCT04639583

20-382

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: Under 24 hours old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Observational Arm

Experimental group

Description:

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.

Treatment:

Device: Near-infrared spectroscopy (NIRS) utilization