N/A
N=21
Use of NIRS in Preterm Population Born at Altitude
Prematurity; Extreme
Bottom Line
View on ClinicalTrials.gov: NCT04639583 ↗Enrolled (actual)
21
Serious AEs
90.5%
Results posted
May 2024
Primary outcome: Primary: Cerebral Regional Oxygen Saturation (cRSO2) — 73.4 percent rcSO2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Near-infrared spectroscopy (NIRS) utilization (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of New Mexico
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cerebral Regional Oxygen Saturation (cRSO2) |
73.4 | — |
| SECONDARY Incidence of Major Complications of Prematurity |
9; 2; 3; 3; 2 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04639583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.