Efficacy of PIMUN by Reducing Intermittent Hypoxia Events

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.

NCT Number	NCT07396103
Lead Sponsor	Pontificia Universidad Catolica de Chile Collaborators: Agencia Nacional de Investigación y Desarrollo
Conditions	Preterm, Apnea of Prematurity, Hypoxemia
Enrollment	20 participants
Start Date	2024-09-01
Primary Completion	2026-05-30 (estimated)
Study Completion	2026-05-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-09