RecruitingNot ApplicableNCT07396103

Efficacy of PIMUN by Reducing Intermittent Hypoxia Events

Clinical Study of Intermittent Hypoxia Reduction Using PIMUN: Efficacy Proof-of-Concept


Sponsor

Pontificia Universidad Catolica de Chile

Enrollment

20 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 30 Days

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Brain NIRS, Polysomnogram, and others for people with apnea of prematurity, hypoxemia, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBrain NIRS

24 hours of Brain regional oxygen saturation by NIRS

OTHERPolysomnogram

4-5 hours of polysomnogram recording

OTHERReactive 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

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NCT07396103


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