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Efficacy of PIMUN by Reducing Intermittent Hypoxia Events
Sponsor: Pontificia Universidad Catolica de Chile
Summary
The goal of this clinical trial is to learn if the use of PIMUN(medical device) works to reduce the intermittent hypoxemia of 24-34 weeks of birth gestational age babies. . It will also learn about the safety of the use of PIMUN. The main questions it aims to answer are: Does PIMUN lower the time of oxygen saturation under 90%? What medical problems do participants have using PIMUN? Researchers will compare the use of PIMUN during 48 hours to 48 hours of usual treatments (not using PIMUN). Participants will: Use/ or not use of PIMUN for a 48 hours period- randomly assigned. Regional brain oxygenation by near infrared spectroscopy (NIRS) monitoring at the first day of each 48 hours period. 4-6 hours of polysomnography at the second day of each intervention. Plasma and urine stress oxygen metabolites at the end of each 48-hours intervention.
Official title: Clinical Study of Intermittent Hypoxia Reduction Using PIMUN: Efficacy Proof-of-Concept
Key Details
Gender
All
Age Range
Any - 30 Days
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-09-01
Completion Date
2026-05-31
Last Updated
2026-02-09
Healthy Volunteers
Yes
Conditions
Interventions
Brain NIRS
24 hours of Brain regional oxygen saturation by NIRS
Polysomnogram
4-5 hours of polysomnogram recording
Reactive oxydative species
Blood and urine samples to detect plasma not albumin bound proteins- neuroprostane and isoflurane
Locations (2)
Clinica San Carlos de Apoquindo
Santiago, Santiago Metropolitan, Chile
UC Christus Clinical Hospital
Santiago, Santiago Metropolitan, Chile