CompletedNot Applicable

Use of NIRS in Preterm Population Born at Altitude

United States21 participantsStarted 2021-10-01

Plain-language 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.

Who can participate

Age range

0 Hours – 24 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cerebral Regional Oxygen Saturation (cRSO2)

Timeframe: first 96 hours of life

Trial details

NCT IDNCT04639583

SponsorUniversity of New Mexico

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30

Results submitted2023-12-19

View on ClinicalTrials.gov More Prematurity; Extreme trials