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RECRUITING
NCT07396103
NA

Efficacy of PIMUN by Reducing Intermittent Hypoxia Events

Sponsor: Pontificia Universidad Catolica de Chile

View on ClinicalTrials.gov

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

Interventions

OTHER

Brain NIRS

24 hours of Brain regional oxygen saturation by NIRS

OTHER

Polysomnogram

4-5 hours of polysomnogram recording

OTHER

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