Use of NIRS in Preterm Population Born at Altitude

Prematurity; Extreme Clinical Trial

Official title:

Utilization of Near-Infrared Spectroscopy Technology to Determine Normative Cerebral Regional Oxygen Saturation in a Preterm Population Born at Altitude

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04639583
• Other study ID #: 20-382
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2024
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Hours to 24 Hours

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Prematurity; Extreme

Intervention

Device:
• Near-infrared spectroscopy (NIRS) utilization
The NIRS devise will be applied so that cerebral regional oxygen saturation (cRSO2) can be measured.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral Regional Oxygen Saturation (cRSO2)	Measure cRSO2 for the first 96 hours of life in infants born preterm.	first 96 hours of life
Secondary	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.	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.