Use of NIRS in Preterm Population Born at Altitude

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Prematurity; Extreme

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study will be a prospective observational study, in which any infant consented to participate in the study will have the NIRS applied for the first 96 hours of life.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Near-infrared spectroscopy (NIRS) utilization

Intervention Type DEVICE

The NIRS devise will be applied so that cerebral regional oxygen saturation (cRSO2) can be measured.

Interventions

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Near-infrared spectroscopy (NIRS) utilization

The NIRS devise will be applied so that cerebral regional oxygen saturation (cRSO2) can be measured.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

0 Hours

Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No