Use of NIRS in Preterm Population Born at Altitude

NCT04639583 | Completed Results DMC FDA Device

• 1 other identifier: 20-382
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity; Extreme

Outcome Measures

Primary Outcomes (1)

• Cerebral Regional Oxygen Saturation (cRSO2)

  Measure cRSO2 for the first 96 hours of life in infants born preterm.

  first 96 hours of life

Secondary Outcomes (1)

• 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.

Study Arms (1)

Observational Arm

EXPERIMENTAL

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.

Device: Near-infrared spectroscopy (NIRS) utilization

Interventions

Near-infrared spectroscopy (NIRS) utilization DEVICE

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

Observational Arm

Eligibility Criteria

• Age: 0 Hours - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Jessie Maxwell, MD, MBA
• Organization: University of New Mexico

JRMaxwell@salud.unm.edu

505-272-3967

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics and Neurosciences

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2020
• First Posted: November 20, 2020
• Study Start: October 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 29, 2024
• Results First Posted: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)