Back to resultsUse of NIRS in Preterm Population Born at Altitude
Primary Purpose
Prematurity; Extreme
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Near-infrared spectroscopy (NIRS) utilization
Sponsored by
About this trial
This is an interventional supportive care trial for Prematurity; Extreme
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.
Sites / Locations
- University of New Mexico
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Observational Arm
Arm 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.
Outcomes
Primary Outcome Measures
cerebral regional oxygen saturation (cRSO2)
Measure cRSO2 for the first 96 hours of life in infants born preterm.
Secondary Outcome Measures
Incidence of Major Complications of Prematurity
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.
Full Information
NCT ID
NCT04639583
First Posted
November 1, 2020
Last Updated
June 30, 2023
Sponsor
University of New Mexico
1. Study Identification
Unique Protocol Identification Number
NCT04639583
Brief Title
Use of NIRS in Preterm Population Born at Altitude
Official Title
Utilization of Near-Infrared Spectroscopy Technology to Determine Normative Cerebral Regional Oxygen Saturation in a Preterm Population Born at Altitude
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity; Extreme
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Observational Arm
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Near-infrared spectroscopy (NIRS) utilization
Intervention Description
The NIRS devise will be applied so that cerebral regional oxygen saturation (cRSO2) can be measured.
Primary Outcome Measure Information:
Title
cerebral regional oxygen saturation (cRSO2)
Description
Measure cRSO2 for the first 96 hours of life in infants born preterm.
Time Frame
first 96 hours of life
Secondary Outcome Measure Information:
Title
Incidence of Major Complications of Prematurity
Description
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Hours
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of NIRS in Preterm Population Born at Altitude
We'll reach out to this number within 24 hrs